Linda Ikuta, MN, RN, CCNS, PHN, and Ksenia Zukowsky, PhD, APRN, NNP-BC ❍ Section Editor Editors ❍ Section
Clinical Issues in Neonatal Care
Got Milk? Effects of Early Enteral Feedings in Patients With Gastroschisis Jennifer B. Lemoine, DNP, APRN, NNP-BC; Rhonda R. Smith, MN, APRN, NNP-BC; Debra White, MSN, RN
ABSTRACT Background: Initiating early enteral intake post-surgical gastroschisis repair may result in better patient outcomes. However, there is lack of evidence and consistency in clinical practice regarding the timing of initiation of feedings, and few studies have determined best practices for post-operative nutritional management. Purpose: To determine whether early nutritional management using a standardized advancement protocol improves outcomes for patients with gastroschisis. Findings/Results: A retrospective study was used, following the implementation of a new early enteral feeding protocol. Patients managed without the new protocol, from January 2007 through December 2009, formed the traditional feeding group, while those receiving post-protocol nutritional management, from January 2010 through December 2012, comprised the early enteral feeding group. The main outcome, measured by length of stay (LOS), and secondary outcomes, including incidence of sepsis, were evaluated; N = 32. There was a statistically significant difference in the scores for LOS (P = .022) and incidence of sepsis (P = .36). No correlation was found between the number of days to initial feeding and LOS (P = .732). However, there was a robust, positive correlation between the number of days to achieve full feedings and LOS (P < .001) Implications for Practice: These findings support the benefit of early initiation of enteral feedings in reducing the incidence of sepsis. Furthermore, they suggest the time to achieve full enteral feedings, not necessarily the timing of initiation of feedings, significantly impacts LOS. Implications for Research: Consideration for future studies include incorporating strategies that combine early enteral feeding initiatives with interventions that allow for quicker onset of full enteral intake. Key Words: enteral feedings, gastroschisis, gastroschisis repair, hospitalization, intestinal defects, length of stay, neonatal intensive care, postoperative feedings, sepsis
G
astroschisis is a congenital anomaly that comprises a full-thickness paraumbilical abdominal wall birth defect associated with herniation of the intestines and requires surgical intervention to correct. National statistics suggest an incidence of 4 to 5 per 10,000 live births and report increasing occurrence over the past 2 decades.1 According to the Centers of Disease Control and Prevention, 1871 infants are born annually in the United States with a gastroschisis defect.2
Although the postoperative survival rate is greater than 90%, gastroschisis is associated with lengthy neonatal intensive care services, resulting in considerable financial and resource implications for both healthcare providers and the families of these infants.3 The mean length of hospitalization is 41 days, and the average cost of care of the gastroschisis patient is $155,629.4 That is roughly 84 times the average cost of $1844 associated with an uncomplicated birth.3,4
BACKGROUND Author Affiliations: College of Nursing and Allied Health Professions, University of Louisiana at Lafayette, Lafayette, Louisiana (Dr Lemoine and Ms White); and Pediatrix Medical Group, Women’s and Children’s Hospital, Lafayette, Louisiana (Dr Lemoine and Ms Smith). No grant support was acquired for this research. The authors declare no conflicts of interest. Correspondence: Jennifer B. Lemoine, DNP, APRN, NNP-BC, College of Nursing and Allied Health Professions, University of Louisiana at Lafayette, 411 E. St Mary Blvd, Lafayette, LA 70508-6460 ([email protected]). Copyright © 2015 by The National Association of Neonatal Nurses DOI: 10.1097/ANC.0000000000000171
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Evisceration of intestinal contents in-utero exposes the uncovered bowel to amniotic fluid and can cause the intestines to become inflamed, thickened, and edematous producing a chemical peritonitis.5 Surgical repair of intestinal defects in the neonatal period further prolongs enteric maturity, enzymatic activity, and impairs mucosa renewal, thus leading to villous atrophy.5 Delayed gastrointestinal motility is a major postoperative complication frequently seen in this patient population; consequently, initiation of Advances in Neonatal Care • Vol. 15, No. 3 • pp. 166-175
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enteral feeding initiation is usually postponed necessitating the prolonged administration of total parenteral nutrition (TPN).5 Although life-saving, prolonged administration of TPN is associated with a greater incidence of infection and end-organ dysfunction, specifically parenteral nutrition associated liver disease.6 To this end, the delay in enteral feeding has compounded effects on intestinal growth and development, possibly leading to a lengthier hospital stay and increased likelihood of infection.5,7 Advances in neonatal intensive care and the development of TPN reduced infant mortality rates for patients with gastroschisis from 60% in the 1960s to 2% to 10% by the mid-1990s.8 Although the mortality rate for gastroschisis defects is continuously reported as low, significant morbidity, including feeding intolerance, failure to thrive, cholestatic liver injury, sepsis, and prolonged duration of hospitalization, occurs in nearly all infants diagnosed with this defect.8,9 Traditionally, postoperative nutritional management of patients with gastroschisis includes nothing by mouth (NPO) coupled with low-intermittent suctioning (LIS) of gastric contents.10 A large-bore naso/ orogastric tube is used to prevent gastrointestinal distension resulting from impaired intestinal motility.10 Postsurgical gastric drainage, characteristically green due to the stasis of biliary and pancreatic secretions, slowly changes to a clear appearance.10 Gastric drainage may persist for several days up to weeks, with initial losses as much as 100 mL/kg per day.10 Enteral feedings are generally initiated when gastric output is reduced to a minimum, allowing for complete cessation of LIS. Subsequently, this delay in the initiation of enteral feedings results in the need for long-term parenteral nutrition.5,7 The cessation of enteral intake is thought to be necessary to prevent aspiration due to the potential for vomiting secondary to a postoperative ileus and possible anastomosis leakage after abdominal surgery.11 Findings of clinical studies, however, purport that traditional restriction of enteral intake after abdominal surgery is not based on scientific evidence, although the benefits of enteral feedings, including decreased rates of clinical sepsis and maintenance of intestinal structure, have been recognized.11 Although healthcare providers look for best evidence-based practices to achieve positive outcomes for patients with gastroschisis, nutritional management with early enteral feedings offers promise. This article describes a nurse practitioner-instituted early enteral feeding protocol (EFP) and the associated outcomes of patients with gastroschisis.
Literature Review Determination of readiness for enteral nutrition after gastroschisis repair is highly subjective, and feeding practices are known to vary greatly within and
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What This Study Adds • Identification of a gap in the literature regarding optimal nutrition management for patients with gastroschisis. • Introduction of an early EFP for postoperative nutritional management of patients with gastroschisis. • Clinician consideration for the early introduction of enteral feedings in combination with initiates that allow for quicker advancement to achieve full enteral intake.
among practices.6,12 However, a review of the literature revealed that early commencement of enteral feedings is beneficial in reducing the incidence of sepsis, thus further reducing the associated human and financial cost of care and treatment.13 Additional findings suggest that the timing of initiation of enteral nutrition following gastroschisis repair independently predicts the time required to achieve TPN cessation and length of hospital stay (LOS).7 An additional factor identified that may influence the time to achieve full enteral intake and LOS is type of enteral feeding—expressed human milk (EHM) versus formula. It has been suggested that the use of EHM may result in faster attainment of full enteral intake by promoting intestinal adaption.6 Among significant findings reported from a recent study are that the time to achieve full enteral feedings and the time to discharge were decreased among those infants exclusively fed EHM.6 It is important to note that this study was not based on standardized feeding guidelines for the rate of enteral feeding advancement, which may impose limitations on these findings.6 Despite evidence that the initiation of early enteral feedings may improve outcomes for patients with gastroschisis, a gap in the literature remains regarding the optimal nutritional management of the postsurgical gastroschisis patient, specifically standardized protocols and best practices for the initiation and advancement of feedings, as well as the type of enteral feeding used (see Table 1 for a complete summary of the research studies included in the review of the literature).
Early EFP The development of the early EFP originated in response to the recognition of the inconsistent management of enteral feeding practices in the postoperative patients with gastroschisis between and among neonatologists and neonatal nurse practitioners (NNPs) in the clinical setting. As with any practice that employs a multidisciplinary team of providers, approaches to the initiation of postoperative enteral feedings vary, with some methods being more aggressive than others.
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181 infants born with a Dependence of neonatal outcomes in gastroschisis defect gastroschisis patients in relation to: from 1990 to 2000 The mode of delivery Place of birth Time from birth to surgery Method of closure/repair Time from repair to commencement of first enteral feeding Incidence of sepsis LOS 73 infants born with a gastroschisis defect from November 2004 to April 2006 22 infants: minimal enteral feeding (MEF) group 51 infants: historical control group
Retrospective, multicenter, descriptive study
Retrospective, single center, descriptive study
Singh et al13
WalterNicolet et al5
Abbreviations: HF, human milk; LOS, length of hospital stay; MEF, minimal enteral feeding; TPN, total parenteral nutrition.
Initiation and evaluation of an early MEF and gradual enteral nutritional advancement (new protocol) on postoperative outcomes of those neonates born with gastroschisis: Duration of TPN Secondary sepsis Surgical complications LOS
Comparison of exclusive HM vs nonexclusive HM fed groups postgastroschisis repair: Time to achieve full feedings Time to discharge
90 infants born with gastroschisis defect between 2000 and 2010 22 infants: exclusive human milk (HM) group 57 infants: nonexclusive HM group
Retrospective, single center, descriptive study
Kohler et al6
Early MEF and controlled increase in enteral feeding advancements postsurgical repair significantly decreased the duration of TPN and reduced LOS. An increased incidence in the rate of sepsis and surgical complications occurred more frequently in the control group
Early enteral feedings (within 10 d of repair) decreases the incidence of infection, duration of TPN and LOS Place and mode of delivery, time from birth to repair, and type of closure did not influence neonatal outcomes
Exclusive use of HM postoperative gastroschisis repair decreases the time to achieve full enteral feeds and time to discharge
Enteral feedings initiated within 5-7 d, instead of the average 15-17 d typical in similar studies, produced more favorable outcomes and are believed to be attributed to faster establishment of bowel function and subsequently shorter time receiving TPN, reduced LOS, and high survival rates
LOS Days on TPN Survival rates
79 infants born with a gastroschisis defect between 1989 and 2009
Retrospective, single center, descriptive study
Kassa and Lilja3
Results/Findings The number of days to the initiation of first feeding post repair independently predicts the time required to achieve TPN cessation, decrease LOS, and reduce the incidence of sepsis, with best outcomes observed when feeds were initiated 7 d postclosure
Interventions/Outcome Measures
570 infants born with a Duration of TPN gastroschisis defect LOS between May 2005 Infectious complications and August 2011
Sample
Retrospective, multicenter, descriptive study
Design
Aljahdali et al7
Author(s)
TABLE 1. Table of Evidence
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The unit did not have a written protocol in place for nutritional management of the patients with gastroschisis prior to the development of the early enteral feeding protocol in 2010. As previously discussed, traditional nutritional management of these patients usually includes NPO status, LIS, and prolonged TPN administration. Consequently, the majority of the providers in the practice would wait until gastric suction had been discontinued before postop enteral feedings were initiated. Likewise, the type of enteral feeding used was inconsistent—EHM versus formula. It was noted that some physicians were inclined to begin enteral feedings sooner, with cycling of LIS being decreased at routine intervals allowing for feedings to be delivered during brief periods when the suction was turned off. Patient response to this somewhat unconventional method was positive. It appeared that these patients experienced fewer feeding challenges and were being discharged earlier than those receiving traditional care. This observation led to an extensive review of the literature in which a gap in best practices for the management of enteral feedings in the postoperative patient with gastroschisis was found. Several studies suggest that the initiation of early enteral feedings in the postoperative patient results in better outcomes. However, no studies have been conducted to determine best practices for the initiation
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of early enteral feedings with a standardized advancement protocol.6,11 The team of neonatologists and NNPs then collaborated to create an early EFP that included the cycling of suction at routine intervals with a standardized increase in enteral intake using EHM exclusively (Table 2). After the development and implementation of this protocol, all gastroschisis patients were then followed by the NNP provider team for the duration of their hospital stay. This was to ensure and maintain consistency in nutritional management and patient care practices.
STUDY SIGNIFICANCE AND PURPOSE The purpose of this retrospective descriptive study was to determine whether early nutritional management using a standardized advancement protocol improves outcomes in patients with gastroschisis. Outcomes of patients with gastroschisis were evaluated for the 3-year period prior to the implementation of an early EFP as compared to the 3-year period following implementation. The research question was, “In neonates born with gastroschisis defects, does cycling of suction with early introduction of enteral feedings (vs waiting until suction is off to initiate feeds) improve patient outcomes?” For the purpose of this study, the operational definition
TABLE 2. Early Enteral Feeding Protocol for the Gastroschisis Patient Cycling of Suction
Initiation of Feeds
By infant’s fifth day of life (or S/P final closure), start cycling suction off for 1 h intervals (regardless of color or volume of gastric output)
Gut stimulation with EHM by seventh day of life (preferably earlier if cycling earlier)
Start with a minimum of off 1 h q 8 h intervals
Start with 1 mL EHM while suction off for the 1 h cycle.
Each day increase interval: • Off 1 h q 6 h • Off 1 h q 4 h • Off 1 h q 3 h • Off 2 h on 1 h • Then to gravity
Once on q 3 h cycle, may start to increase EHM volume, with decreasing suction time
Once off suction. Increasing should start at 10 mL/kg per day increase for several days, until tolerating 40-50 mL/kg per day. Then consider increase by 20 mL/kg per day as tolerated. If not tolerated, hold feeds at current volume or reduce feeding increase to 10 mL/kg per day No sweet-ease for these patients (due to osmolality) Discharge criteria: Should be on full feeds (ad lib) for minimum of 3-4 d with consistent weight gain and tolerating feeds Plan to room-in for 2-3 d following ad lib feeds to monitor feeding tolerance Abbreviations: EHM, expressed human milk; S/P, status post.
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of early enteral feedings was defined as feedings initiated within 5 to 7 days of life. The primary outcome measure was LOS. Secondary outcome measures during hospitalization include (1) the number of days from primary closure to initiation of feedings; (2) the number of days from birth to achieve full enteral feedings; (3) the number of days from initiation of feedings to achieve full enteral intake; (4) total number of days on TPN; (5) incidence of sepsis; and (6) peak direct bilirubin levels.
METHODS Setting and Design The setting for this study was a 60-bed, level III regional transport neonatal intensive care unit (NICU). A retrospective descriptive design was used. The study design relied on a new early EFP (implemented January 2010) that was based on published best evidence and developed by a team of neonatologists and nurse practitioners who provide postoperative care to patients with gastroschisis, including nutritional management. Sample The overall incidence of neonates born with a gastroschisis defect in the state of Louisiana is 3.73 per 10,000 live births.14 Because of this relatively low frequency, the available sample size is self-limiting. A convenience sample was used for this single center study. Neonates included in the study met the following criteria: • • • •
Gastroschisis defect (single anomaly) Gestation age of 35 weeks or more Surgical repair of the defect Initiation of enteral feedings
Those neonates who originally met the above criteria but experienced surgical complications requiring extensive repeated repairs and/or died prior to discharge were excluded from this study.
Procedure Following internal and external institution review board approval, charts were reviewed and data were collected for neonates with gastroschisis admitted to the NICU over a 6-year period. A proprietary software system was used to generate clinical admission, discharge, and daily progress notes. All site-specific data are consolidated and stored within a data warehouse. A retrospective electronic chart review was conducted through the data warehouse by 2 individuals using a template developed for data collection (see Figure 1). The primary investigator then examined all data collected for accuracy. Because of the precision of this system, which is also used for coding and billing purposes, and the type of data collected, there was no missing data.
Those neonates who did not receive the early EFP, from January 2007 through December 2009, were included in the traditional feeding (TF) group. Those neonates who were managed with the early EFP, January 2010 to December 2012, comprised the early initiation EFP group. Subsequently, those infants who were found to be “complicated gastroschisis patients” requiring multiple surgical corrections fell outside of the parameters of the protocol, and a patient specific, individualized enteral feeding plan was established. These subjects were excluded from the study.
Data Analyses All data generated from chart review were entered by 1 member of the research team into a password protected Excel spreadsheet created specifically for this study. Each entry was double checked for accuracy by a second team member. The data were then exported by the primary investigator into SPSS 22 software for data analysis. Demographic variables were tabulated using descriptive statistics and/or frequency distributions as appropriate. A t test for independent samples was conducted to compare variables between the groups; alpha was set at P < .05. The Levene test for equality of variances was also used. The Pearson correlation coefficient was computed to assess these mean group differences; correlation is significant at the 0.01 level (two-tailed). Finally, the chi-square test was used to assess group difference when the dependent variable was measured on a nominal scale; significance was set at 0.05.
RESULTS Subject Characteristics During the study period (January 2007-December 2012), 49 neonates were born with a gastroschisis defect and admitted to the NICU. A total of 15 infants did not meet the inclusion criteria and were immediately excluded from this study. Through data cleaning and consistency checks 2 outliers were identified in the TF group. Further review revealed a radical alteration in the nutritional management of these subjects. These outliers were believed not to be representative of the sample population and were subsequently removed from the data set.15 As a result, study participants included 32 neonates born with a gastroschisis defect who underwent surgical repair and received enteral feedings; TF group, n = 16, and EFP group, n = 16 (Figure 2). There were no statistically significant differences in demographic data found between the 2 groups for gestational age, maternal age, sex, race/ethnicity, mode of delivery, and type of defect repair (closure). All 16 infants in the EFP group received EHM feedings, whereas only 10 infants (62.50%) in the TF group received EHM. This difference, although not www.advancesinneonatalcare.org
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FIGURE 1
Gastroschisis data collection sheet.
statistically significant, can be attributed to the initiation of the early EFP, which stipulates consistent use of EHM. As previously stated, complex gastroschisis patients, who reflect degree of illness, were excluded from this study. In addition, there were no other associated comorbidities noted, which may have contributed to group differences or affected the results of this study. Table 3 provides a complete overview of demographic characteristics between groups.
Primary Outcome Measures The effectiveness of interventions and positive patient outcomes is often measured by LOS. This variable, therefore, was chosen as the primary
outcome measure for this study. An independent t test was conducted to compare the difference between the 2 groups. Results indicate a statistically significance difference in the scores for LOS between the TF group (M = 28.25, standard deviation [SD] = 8.3467) and the early initiation feeding protocol group (M = 35.31, SD = 8.2196), t30 = −2.412, P = 0.022 two-tailed. It can be inferred that patients in the TF group had a shorter LOS, suggesting that the initiation of early enteral feedings did not reduce the length of hospitalization in the EFP group.
Secondary Outcome Measures Although the primary outcome measure did not demonstrate that the initiation of early enteral feedings
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reduced LOS, a statistically significance difference was seen in 3 of the secondary outcome measures— incidence of sepsis, the number of days from initiation of feeding to achieve full enteral intake, and the number of days from defect closure to the initial feeding. Most notably, the incidence of sepsis between the groups was statistically significant {χ2 (1, N = 32) = 4.386; P = .036}. Of those infants who became septic (n = 9), 77.8% (n = 7) were in the TF group, whereas only 22% (n = 2) were in the EFP group (Table 4). Likewise, there was a statistically significant difference in the scores for the number of days from the initiation of feedings to achieve full enteral intake between the TF group (M = 11.63, SD = 8.397) and the EFP group (M = 19.38, SD = 6.888), t30= 2.854, P = .008, and the number of days from primary closure of the defect to the initial feeding between the TF group (M = 9.75, SD = 5.905) versus the EFP group (M = 6.31, SD = 1.991), t18.4= 2.207, P = .009. These finding are not surprising as they are consistent with the nutritional management guidelines
FIGURE 2
Sample traditional feeding (TF) group and early enteral feeding protocol (EFP) group.
TABLE 3. Demographic Characteristics of Neonatal Gastroschisis Patients (N = 32)a TF Group (n = 16)
EFP Group (n = 16)
Mean (SD)
Median
Range
Mean (SD)
Median
Range
Gestational age (d/wk)
257 (7.05) 36 5/7
256 36 4/7
247-274 35 2/7-39 1/7
260 (6.26) 37 1/7
260 37 1/7
245-273 35 0/7-39 0/7
Maternal age
22 (4.39)
20
15-30
22 (5.09)
21
17-32
TF Group
EFP Group
Frequency
%
Frequency
%
P
6 10
37.50% 62.50%
4 12
25.00% 75.00%
0.445
3 12 1
18.75% 75.00% 6.25%
4 12 0
25.00% 75.00% 0.00%
0.565
10 6
62.50% 37.50%
8 8
50.00% 50.00%
0.193
Primary
14
87.50%
13
81.25%
0.595
Silo
2
12.50%
3
18.75%
10 6
62.50% 37.50%
16 0
100% 0.00%
Sex Female Male Race/ethnicity African American Caucasian Mixed race Mode of delivery Vaginal Cesarean section Type of closure
Type of feeding EHM Formula
0.150
All infants in the EFP group received EHM as established by the new feeding protocol. Cross table data were run for demographics for group assignment. There were no statistically significant differences found. Groups were homogeneous. Abbreviations: EFP, early enteral feeding protocol; EHM, expressed human milk; TF, traditional feeding.
a
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TABLE 4. Differences Between Groups for Incidence of Sepsis Traditional Feeding Group (n = 16)
Early Enteral Feeding Group (n = 16)
df
χ2
Yes
7 (43.8%)
2 (12.5%)
1
4.386
No
9 (56.2%)
14 (87.5%)
Acquired Infection
P .036
a
Chi-square test, α ≤ 0.05
a
established in the early EFP, which include early initiation of enteral feedings as well as a standardized rate for feeding advancement. Measures for which there were no statistically significant differences found between the groups include the number of days from birth to achieve full enteral feedings, total number of days on TPN, and peak direct bilirubin levels (Table 5). A Pearson product-moment correlation coefficient was computed to assess the relationship between the length of stay and the initiation of early enteral feedings. There was no statistically significant correlation between the 2 variables, r = 0.63, N = 32, P = .732. There was, however, a robust positive correlation between several of the secondary outcome measures— the number of days to achieve full feedings and the LOS, the total number of days receiving TPN and the LOS, and the total number of days receiving TPN and the number of days to achieve full feedings. These findings suggest that the time to achieve full enteral feedings, with subsequent cessation of TPN, significantly impacts LOS (see Table 6 for complete data analysis information).
DISCUSSION Because of the high incidence of morbidity associated with this defect, the team was particularly interested
in the length of hospitalization, which must be considered when examining patient outcomes and overall cost of care. The selection of LOS as the primary variable is also consistent with the findings of similar studies, which infer that the initiation of early enteral feedings in postoperative patients with gastroschisis is associated with more favorable outcomes.3,6,7,13 Nutritional management of patients with gastroschisis adhered to these new guidelines during the 3 years following the implementation of the early initiation feeding protocol. Over time, the initiation of the protocol became second nature and the team believed that progress was being made. It was felt that the group had developed an evidence-based practice model that could be shared with other healthcare providers who care for these types of patients. Unlike results reported by other researchers, the findings of this study did not indicate a reduction in LOS with the initiation of the early EFP.3,6,7 However, it is important to note that the mean LOS, 35 days in the EFP group, was less than the reported national mean of 41 days.4 In addition, consideration must be given to the fact that no other study included the initiation of early enteral feedings in combination with a standardized feeding advancement protocol, as used in this study, to examine outcomes of patients with gastroschisis. A statistically and clinically significant finding of this study was the reduction of the incidence of sepsis in
TABLE 5. Differences Between Groups for Primary and Secondary Outcome Measures TF Group (n = 16) Mean (SD)
Variables
Median
EFP Group (n = 16) Mean (SD)
Median
t −2.412
df
P*
30
.022*
28.250 (±8.3467)
31.500
35.313 (±8.219)
33.500
# days from primary closure to initiation of feeds
9.75 (±5.905)
9.50
6.31 (±1.911)
6.00
2.207
# days from birth to achieve full feedings
22.375 (±7.990)
22.00
27.188 (±1.844)
26.00
−1.844
30
.075
# days from first feeding to full intake
11.63 (±8.397)
9.00
19.38 (±6.888)
18.00
−2.854
30
.008*
# days on TPN
21.56 (±8.107)
23.50
26.25 (±7.000)
25.00
−1.751
30
.090
−1.032
30
.310
Length of hospital stay
Direct bilirubin levels
1.250 (±0.9953)
1.050
1.631 (±1.09)
1.250
18.366 .009*
*Independent t test, α ≤ 0.05. Abbreviations: EFP, early enteral feeding protocol; TF, traditional feeding; TPN, total parenteral nutrition.
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TABLE 6. Results of the Pearson Correlation Coefficienta Primary Outcome Variable Length of stay # days 0 to initial feeding
0.063 (NS)
Secondary outcome variables Length of stay
# days to full feedings
Length of stay
1.00
# days to full feedings
0.895b
1.00
Total # days TPN
0.917b
0.942b
Total # days TPN
1.00
Listwise, N = 32. bCorrelation is significant at the 0.01 level (two-tailed). Abbreviations: NS, not significant; TPN, total parenteral nutrition. a
the EFP group. This finding suggests that the introduction of early enteral feedings may better establish natural gut flora, diminish the inflammatory process, and decrease pathogen proliferation.16
Study Limitations There are several limitations to this study. First, this is a retrospective study that used a convenience sample and lacked randomization, thereby imposing limits to generalizability. Second, chart review occurred retrospectively of physician documentation instead of being performed in real time. The study was also conducted at a single-center site and the sample size was relatively small. In addition, enteral feedings were advanced in the TF group on the basis of individual judgment versus a standardized advancement protocol. This difference may have inadvertently contributed to the increased LOS in the
EFP group for those infants who may have tolerated more aggressive advancements of enteral intake outside of the protocol parameters. Of particular importance is a central line catheter care and maintenance policy change initiated in 2009. Although there is sufficient evidence that suggests that early enteral feeding, particularly with EHM, may increase immune function, this change may have influenced the decrease in incidence of sepsis for the EFP group.
RECOMMENDATIONS AND IMPLICATIONS FOR FUTURE PRACTICE The findings of this study did not support the hypothesized benefits of an early EFP to reduce LOS but suggest that the time to achieve full enteral feedings significantly impacts the length of
Summary of Recommendations for Practice and Research What we know:
• Lack of consistency exists within and among clinical practices regarding the timing of initiation of enteral feedings for patients with gastroschisis • No best practices have been established for the optimal nutritional management of patients with gastroschisis • Time to achieve full enteral intake has a significant impact on LOS for patients with gastroschisis
What needs to be studied:
• Large multicenter randomized control trials to determine best practices for the nutritional management of patients with gastroschisis • Outcomes of infants who are fed human milk versus formula postsurgical gastroschisis repair
What we can do today:
• Establish consistent nutritional management of patients with gastroschisis within clinical groups • Incorporate early enteral feedings feeding strategies postgastroschisis repair • Consider more aggressive advancement of enteral feeding volumes to achieve quicker full enteral intake in patients with gastroschisis www.advancesinneonatalcare.org
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hospitalization. Because of the relatively low incidence of gastroschisis, a large multicenter randomized controlled trial should be conducted to increase generalizability and statistical strength. It is also important to recognize that the decreased incidence of sepsis found in the early EFP group infers that early enteral feedings may offer the advantage of increased immune function. Therefore, consideration for future studies may warrant incorporating strategies that combine early enteral feeding initiatives with interventions that allow the clinician to more rapidly advance feedings to achieve quicker onset of full intake.
6. 7. 8. 9.
10. 11. 12.
References 1. Holland AJ, Walker K, Badawi N. Gastroschisis: an update. Pediatr Surg Int. 2010;26(8):871-878. doi: 10.1007/s00383-010-2679-1. 2. Centers for Disease Control and Prevention. (CDC). Data and statistics in the United States. http://www.cdc.gov/ncbddd/birthdefects/ data.html. Published 2013. Accessed March 12, 2014. 3. Kassa A, Lilja HE. Predictors of postnatal outcome in neonates with gastroschisis. J Pediatr Surg. 2011;46:2108-2114. doi: 10.1016/j. jpedsurg.2011.07.012. 4. Centers for Disease Control and Prevention (CDC). Hospital stays, hospital charges, and in-hospital deaths among infants with selected birth defects—United States, 2003. MMWR Morb Mortal Wkly Rep. 2007;56(2):25-29. 5. Walter-Nicolet E, Rousseau V, Kieffer F, et al. Neonatal outcome of gastroschisis is mainly influenced by nutritional management. J
13. 14. 15.
16.
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Pediatr Gastroenterol Nutr. 2009 ; 48 : 612-617. doi: 10.1097/ MPG.0b013e31818c5281. Kohler JA, Perkins AM, Bass WT. Human milk versus formula after gastroschisis repair: effects on time to full feeds and time to discharge. J Perinatol. 2013;33(8):627-630. doi: 10.1038/jp.2013.27. Aljahdali A, Mohajerani N, Skarsgard E, et al. Effect of timing of enteral feeding on outcome in gastroschisis. J Pediatr Surg. 2013;48:971-976. doi: 10.1016/j.pedsurg.2013.02.014. Bradnock TJ, Marven S, Owen A, et al. Gastroschisis: one year outcomes from national cohort study. BMJ. 2011;343:d6749. doi: 10.1136/ bmj.d6749. Clark RH, Walker MW, Gauderer MWL. Prevalence of gastroschisis and association hospital time continue to rise in neonates who are admitted for intensive care. J Pediatr Surg. 2009;42(5):815-818. doi: 1016/j.pedsurg.2009.02.018. Williams T, Butler R, Sundem T. Management of the infant with gastroschisis: a comprehensive review of the literature. Newborn Infant Nurs Rev. 2003;3(2):55-63. doi: 10.1053/nbin.2003.36106. Ekingen G, Ceran C, Haulk-Guvenc B, Tuzlaci A, Kahraman H. Early enteral feeding in newborn surgical patients. Nutr. 2005;21:142-146. doi:10.1016/j.nut.2004.10.003. Emil S, Canvasser N, Chen T, Friedrich E, Su W. Contemporary 2-year outcomes of complex gastroschisis. J Pediatr Surg. 2012;47(8):15211528. doi: 10.1016/j.jpedsurg.2011.12.023. Singh SJ, Fraser A, Leditschke JF, et al. Gastroschisis: determinants of neonatal outcome. Pediatr Surg Int. 2003;19:260-265. doi: 10.1007/ s00383-002-0886-0. National Birth Defects Prevention Network. Birth defects state profile. http://www.nbdpn.org/docs/LA_2010_C.pdf. Published 2010. Accessed February 1, 2014. Polit DE, Beck CT. Designing a quantitative analysis strategy: from data collection to interpretation. In: Nursing Research Generating and Assessing Evidence for Nursing Practice. 8th ed. Philadelphia, PA: Lippincott; 2008:642-663. Sharma R, Tepas JJ, Hudak ML, et al. Neonatal gut injury and infection rate: impact of surgical debridement on outcome. Pediatr Surg Int. 2005;21:977-982. doi: 10.1097/MPG.0b013e31818c5281.
Call for Manuscripts for Clinical Issues in Neonatal Care Section Share your expertise with your colleagues!
Please consider submitting a manuscript related to your neonatal clinical practice. Section Overview: Manuscripts submitted for this section contain information that is fundamental to neonatal nursing practice. The reader will gain knowledge from the article that enriches and expands clinical knowledge and practice. We welcome policy changes, critical review of the literature, and examples of clinical excellence, overall these manuscripts capture the essence neonatal clinical care. Examples of these types of articles are: • Concept analysis of ideas central to neonatal nursing • Clinical excellence related to specific problems • Descriptions of essential nursing care strategies for specific diagnosis from the novice to the expert, or targeted to a specific audience such as the new staff nurse or the advanced practice nurse • Care practices (or bundles) based on evidence-based interventions • Neonatal assessment processes • Neonatal concepts that pertain to all levels of nursing For more details on manuscript submissions. Please see the author guidelines for Advances in Neonatal Care available at http://edmgr.ovid.com/anc/accounts/ifauth.htm Please contact Ksenia Zukowsky, PhD, APRN, NNP-BC, or Linda Ikuta, RN, MN, CCNS, PHN, Section Editors at [email protected] or [email protected] for questions.
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Got Milk? Effects of Early Enteral Feedings in Patients With Gastroschisis Jennifer B. Lemoine, DNP, APRN, NNP-BC; Rhonda R. Smith, MN, APRN, NNP-BC; Debra White, MSN, RN
ABSTRACT Background: Initiating early enteral intake post-surgical gastroschisis repair may result in better patient outcomes. However, there is lack of evidence and consistency in clinical practice regarding the timing of initiation of feedings, and few studies have determined best practices for post-operative nutritional management. Purpose: To determine whether early nutritional management using a standardized advancement protocol improves outcomes for patients with gastroschisis. Findings/Results: A retrospective study was used, following the implementation of a new early enteral feeding protocol. Patients managed without the new protocol, from January 2007 through December 2009, formed the traditional feeding group, while those receiving post-protocol nutritional management, from January 2010 through December 2012, comprised the early enteral feeding group. The main outcome, measured by length of stay (LOS), and secondary outcomes, including incidence of sepsis, were evaluated; N = 32. There was a statistically significant difference in the scores for LOS (P = .022) and incidence of sepsis (P = .36). No correlation was found between the number of days to initial feeding and LOS (P = .732). However, there was a robust, positive correlation between the number of days to achieve full feedings and LOS (P < .001) Implications for Practice: These findings support the benefit of early initiation of enteral feedings in reducing the incidence of sepsis. Furthermore, they suggest the time to achieve full enteral feedings, not necessarily the timing of initiation of feedings, significantly impacts LOS. Implications for Research: Consideration for future studies include incorporating strategies that combine early enteral feeding initiatives with interventions that allow for quicker onset of full enteral intake. Key Words: enteral feedings, gastroschisis, gastroschisis repair, hospitalization, intestinal defects, length of stay, neonatal intensive care, postoperative feedings, sepsis
G
astroschisis is a congenital anomaly that comprises a full-thickness paraumbilical abdominal wall birth defect associated with herniation of the intestines and requires surgical intervention to correct. National statistics suggest an incidence of 4 to 5 per 10,000 live births and report increasing occurrence over the past 2 decades.1 According to the Centers of Disease Control and Prevention, 1871 infants are born annually in the United States with a gastroschisis defect.2
Although the postoperative survival rate is greater than 90%, gastroschisis is associated with lengthy neonatal intensive care services, resulting in considerable financial and resource implications for both healthcare providers and the families of these infants.3 The mean length of hospitalization is 41 days, and the average cost of care of the gastroschisis patient is $155,629.4 That is roughly 84 times the average cost of $1844 associated with an uncomplicated birth.3,4
BACKGROUND Author Affiliations: College of Nursing and Allied Health Professions, University of Louisiana at Lafayette, Lafayette, Louisiana (Dr Lemoine and Ms White); and Pediatrix Medical Group, Women’s and Children’s Hospital, Lafayette, Louisiana (Dr Lemoine and Ms Smith). No grant support was acquired for this research. The authors declare no conflicts of interest. Correspondence: Jennifer B. Lemoine, DNP, APRN, NNP-BC, College of Nursing and Allied Health Professions, University of Louisiana at Lafayette, 411 E. St Mary Blvd, Lafayette, LA 70508-6460 ([email protected]). Copyright © 2015 by The National Association of Neonatal Nurses DOI: 10.1097/ANC.0000000000000171
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Evisceration of intestinal contents in-utero exposes the uncovered bowel to amniotic fluid and can cause the intestines to become inflamed, thickened, and edematous producing a chemical peritonitis.5 Surgical repair of intestinal defects in the neonatal period further prolongs enteric maturity, enzymatic activity, and impairs mucosa renewal, thus leading to villous atrophy.5 Delayed gastrointestinal motility is a major postoperative complication frequently seen in this patient population; consequently, initiation of Advances in Neonatal Care • Vol. 15, No. 3 • pp. 166-175
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enteral feeding initiation is usually postponed necessitating the prolonged administration of total parenteral nutrition (TPN).5 Although life-saving, prolonged administration of TPN is associated with a greater incidence of infection and end-organ dysfunction, specifically parenteral nutrition associated liver disease.6 To this end, the delay in enteral feeding has compounded effects on intestinal growth and development, possibly leading to a lengthier hospital stay and increased likelihood of infection.5,7 Advances in neonatal intensive care and the development of TPN reduced infant mortality rates for patients with gastroschisis from 60% in the 1960s to 2% to 10% by the mid-1990s.8 Although the mortality rate for gastroschisis defects is continuously reported as low, significant morbidity, including feeding intolerance, failure to thrive, cholestatic liver injury, sepsis, and prolonged duration of hospitalization, occurs in nearly all infants diagnosed with this defect.8,9 Traditionally, postoperative nutritional management of patients with gastroschisis includes nothing by mouth (NPO) coupled with low-intermittent suctioning (LIS) of gastric contents.10 A large-bore naso/ orogastric tube is used to prevent gastrointestinal distension resulting from impaired intestinal motility.10 Postsurgical gastric drainage, characteristically green due to the stasis of biliary and pancreatic secretions, slowly changes to a clear appearance.10 Gastric drainage may persist for several days up to weeks, with initial losses as much as 100 mL/kg per day.10 Enteral feedings are generally initiated when gastric output is reduced to a minimum, allowing for complete cessation of LIS. Subsequently, this delay in the initiation of enteral feedings results in the need for long-term parenteral nutrition.5,7 The cessation of enteral intake is thought to be necessary to prevent aspiration due to the potential for vomiting secondary to a postoperative ileus and possible anastomosis leakage after abdominal surgery.11 Findings of clinical studies, however, purport that traditional restriction of enteral intake after abdominal surgery is not based on scientific evidence, although the benefits of enteral feedings, including decreased rates of clinical sepsis and maintenance of intestinal structure, have been recognized.11 Although healthcare providers look for best evidence-based practices to achieve positive outcomes for patients with gastroschisis, nutritional management with early enteral feedings offers promise. This article describes a nurse practitioner-instituted early enteral feeding protocol (EFP) and the associated outcomes of patients with gastroschisis.
Literature Review Determination of readiness for enteral nutrition after gastroschisis repair is highly subjective, and feeding practices are known to vary greatly within and
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What This Study Adds • Identification of a gap in the literature regarding optimal nutrition management for patients with gastroschisis. • Introduction of an early EFP for postoperative nutritional management of patients with gastroschisis. • Clinician consideration for the early introduction of enteral feedings in combination with initiates that allow for quicker advancement to achieve full enteral intake.
among practices.6,12 However, a review of the literature revealed that early commencement of enteral feedings is beneficial in reducing the incidence of sepsis, thus further reducing the associated human and financial cost of care and treatment.13 Additional findings suggest that the timing of initiation of enteral nutrition following gastroschisis repair independently predicts the time required to achieve TPN cessation and length of hospital stay (LOS).7 An additional factor identified that may influence the time to achieve full enteral intake and LOS is type of enteral feeding—expressed human milk (EHM) versus formula. It has been suggested that the use of EHM may result in faster attainment of full enteral intake by promoting intestinal adaption.6 Among significant findings reported from a recent study are that the time to achieve full enteral feedings and the time to discharge were decreased among those infants exclusively fed EHM.6 It is important to note that this study was not based on standardized feeding guidelines for the rate of enteral feeding advancement, which may impose limitations on these findings.6 Despite evidence that the initiation of early enteral feedings may improve outcomes for patients with gastroschisis, a gap in the literature remains regarding the optimal nutritional management of the postsurgical gastroschisis patient, specifically standardized protocols and best practices for the initiation and advancement of feedings, as well as the type of enteral feeding used (see Table 1 for a complete summary of the research studies included in the review of the literature).
Early EFP The development of the early EFP originated in response to the recognition of the inconsistent management of enteral feeding practices in the postoperative patients with gastroschisis between and among neonatologists and neonatal nurse practitioners (NNPs) in the clinical setting. As with any practice that employs a multidisciplinary team of providers, approaches to the initiation of postoperative enteral feedings vary, with some methods being more aggressive than others.
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181 infants born with a Dependence of neonatal outcomes in gastroschisis defect gastroschisis patients in relation to: from 1990 to 2000 The mode of delivery Place of birth Time from birth to surgery Method of closure/repair Time from repair to commencement of first enteral feeding Incidence of sepsis LOS 73 infants born with a gastroschisis defect from November 2004 to April 2006 22 infants: minimal enteral feeding (MEF) group 51 infants: historical control group
Retrospective, multicenter, descriptive study
Retrospective, single center, descriptive study
Singh et al13
WalterNicolet et al5
Abbreviations: HF, human milk; LOS, length of hospital stay; MEF, minimal enteral feeding; TPN, total parenteral nutrition.
Initiation and evaluation of an early MEF and gradual enteral nutritional advancement (new protocol) on postoperative outcomes of those neonates born with gastroschisis: Duration of TPN Secondary sepsis Surgical complications LOS
Comparison of exclusive HM vs nonexclusive HM fed groups postgastroschisis repair: Time to achieve full feedings Time to discharge
90 infants born with gastroschisis defect between 2000 and 2010 22 infants: exclusive human milk (HM) group 57 infants: nonexclusive HM group
Retrospective, single center, descriptive study
Kohler et al6
Early MEF and controlled increase in enteral feeding advancements postsurgical repair significantly decreased the duration of TPN and reduced LOS. An increased incidence in the rate of sepsis and surgical complications occurred more frequently in the control group
Early enteral feedings (within 10 d of repair) decreases the incidence of infection, duration of TPN and LOS Place and mode of delivery, time from birth to repair, and type of closure did not influence neonatal outcomes
Exclusive use of HM postoperative gastroschisis repair decreases the time to achieve full enteral feeds and time to discharge
Enteral feedings initiated within 5-7 d, instead of the average 15-17 d typical in similar studies, produced more favorable outcomes and are believed to be attributed to faster establishment of bowel function and subsequently shorter time receiving TPN, reduced LOS, and high survival rates
LOS Days on TPN Survival rates
79 infants born with a gastroschisis defect between 1989 and 2009
Retrospective, single center, descriptive study
Kassa and Lilja3
Results/Findings The number of days to the initiation of first feeding post repair independently predicts the time required to achieve TPN cessation, decrease LOS, and reduce the incidence of sepsis, with best outcomes observed when feeds were initiated 7 d postclosure
Interventions/Outcome Measures
570 infants born with a Duration of TPN gastroschisis defect LOS between May 2005 Infectious complications and August 2011
Sample
Retrospective, multicenter, descriptive study
Design
Aljahdali et al7
Author(s)
TABLE 1. Table of Evidence
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The unit did not have a written protocol in place for nutritional management of the patients with gastroschisis prior to the development of the early enteral feeding protocol in 2010. As previously discussed, traditional nutritional management of these patients usually includes NPO status, LIS, and prolonged TPN administration. Consequently, the majority of the providers in the practice would wait until gastric suction had been discontinued before postop enteral feedings were initiated. Likewise, the type of enteral feeding used was inconsistent—EHM versus formula. It was noted that some physicians were inclined to begin enteral feedings sooner, with cycling of LIS being decreased at routine intervals allowing for feedings to be delivered during brief periods when the suction was turned off. Patient response to this somewhat unconventional method was positive. It appeared that these patients experienced fewer feeding challenges and were being discharged earlier than those receiving traditional care. This observation led to an extensive review of the literature in which a gap in best practices for the management of enteral feedings in the postoperative patient with gastroschisis was found. Several studies suggest that the initiation of early enteral feedings in the postoperative patient results in better outcomes. However, no studies have been conducted to determine best practices for the initiation
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of early enteral feedings with a standardized advancement protocol.6,11 The team of neonatologists and NNPs then collaborated to create an early EFP that included the cycling of suction at routine intervals with a standardized increase in enteral intake using EHM exclusively (Table 2). After the development and implementation of this protocol, all gastroschisis patients were then followed by the NNP provider team for the duration of their hospital stay. This was to ensure and maintain consistency in nutritional management and patient care practices.
STUDY SIGNIFICANCE AND PURPOSE The purpose of this retrospective descriptive study was to determine whether early nutritional management using a standardized advancement protocol improves outcomes in patients with gastroschisis. Outcomes of patients with gastroschisis were evaluated for the 3-year period prior to the implementation of an early EFP as compared to the 3-year period following implementation. The research question was, “In neonates born with gastroschisis defects, does cycling of suction with early introduction of enteral feedings (vs waiting until suction is off to initiate feeds) improve patient outcomes?” For the purpose of this study, the operational definition
TABLE 2. Early Enteral Feeding Protocol for the Gastroschisis Patient Cycling of Suction
Initiation of Feeds
By infant’s fifth day of life (or S/P final closure), start cycling suction off for 1 h intervals (regardless of color or volume of gastric output)
Gut stimulation with EHM by seventh day of life (preferably earlier if cycling earlier)
Start with a minimum of off 1 h q 8 h intervals
Start with 1 mL EHM while suction off for the 1 h cycle.
Each day increase interval: • Off 1 h q 6 h • Off 1 h q 4 h • Off 1 h q 3 h • Off 2 h on 1 h • Then to gravity
Once on q 3 h cycle, may start to increase EHM volume, with decreasing suction time
Once off suction. Increasing should start at 10 mL/kg per day increase for several days, until tolerating 40-50 mL/kg per day. Then consider increase by 20 mL/kg per day as tolerated. If not tolerated, hold feeds at current volume or reduce feeding increase to 10 mL/kg per day No sweet-ease for these patients (due to osmolality) Discharge criteria: Should be on full feeds (ad lib) for minimum of 3-4 d with consistent weight gain and tolerating feeds Plan to room-in for 2-3 d following ad lib feeds to monitor feeding tolerance Abbreviations: EHM, expressed human milk; S/P, status post.
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of early enteral feedings was defined as feedings initiated within 5 to 7 days of life. The primary outcome measure was LOS. Secondary outcome measures during hospitalization include (1) the number of days from primary closure to initiation of feedings; (2) the number of days from birth to achieve full enteral feedings; (3) the number of days from initiation of feedings to achieve full enteral intake; (4) total number of days on TPN; (5) incidence of sepsis; and (6) peak direct bilirubin levels.
METHODS Setting and Design The setting for this study was a 60-bed, level III regional transport neonatal intensive care unit (NICU). A retrospective descriptive design was used. The study design relied on a new early EFP (implemented January 2010) that was based on published best evidence and developed by a team of neonatologists and nurse practitioners who provide postoperative care to patients with gastroschisis, including nutritional management. Sample The overall incidence of neonates born with a gastroschisis defect in the state of Louisiana is 3.73 per 10,000 live births.14 Because of this relatively low frequency, the available sample size is self-limiting. A convenience sample was used for this single center study. Neonates included in the study met the following criteria: • • • •
Gastroschisis defect (single anomaly) Gestation age of 35 weeks or more Surgical repair of the defect Initiation of enteral feedings
Those neonates who originally met the above criteria but experienced surgical complications requiring extensive repeated repairs and/or died prior to discharge were excluded from this study.
Procedure Following internal and external institution review board approval, charts were reviewed and data were collected for neonates with gastroschisis admitted to the NICU over a 6-year period. A proprietary software system was used to generate clinical admission, discharge, and daily progress notes. All site-specific data are consolidated and stored within a data warehouse. A retrospective electronic chart review was conducted through the data warehouse by 2 individuals using a template developed for data collection (see Figure 1). The primary investigator then examined all data collected for accuracy. Because of the precision of this system, which is also used for coding and billing purposes, and the type of data collected, there was no missing data.
Those neonates who did not receive the early EFP, from January 2007 through December 2009, were included in the traditional feeding (TF) group. Those neonates who were managed with the early EFP, January 2010 to December 2012, comprised the early initiation EFP group. Subsequently, those infants who were found to be “complicated gastroschisis patients” requiring multiple surgical corrections fell outside of the parameters of the protocol, and a patient specific, individualized enteral feeding plan was established. These subjects were excluded from the study.
Data Analyses All data generated from chart review were entered by 1 member of the research team into a password protected Excel spreadsheet created specifically for this study. Each entry was double checked for accuracy by a second team member. The data were then exported by the primary investigator into SPSS 22 software for data analysis. Demographic variables were tabulated using descriptive statistics and/or frequency distributions as appropriate. A t test for independent samples was conducted to compare variables between the groups; alpha was set at P < .05. The Levene test for equality of variances was also used. The Pearson correlation coefficient was computed to assess these mean group differences; correlation is significant at the 0.01 level (two-tailed). Finally, the chi-square test was used to assess group difference when the dependent variable was measured on a nominal scale; significance was set at 0.05.
RESULTS Subject Characteristics During the study period (January 2007-December 2012), 49 neonates were born with a gastroschisis defect and admitted to the NICU. A total of 15 infants did not meet the inclusion criteria and were immediately excluded from this study. Through data cleaning and consistency checks 2 outliers were identified in the TF group. Further review revealed a radical alteration in the nutritional management of these subjects. These outliers were believed not to be representative of the sample population and were subsequently removed from the data set.15 As a result, study participants included 32 neonates born with a gastroschisis defect who underwent surgical repair and received enteral feedings; TF group, n = 16, and EFP group, n = 16 (Figure 2). There were no statistically significant differences in demographic data found between the 2 groups for gestational age, maternal age, sex, race/ethnicity, mode of delivery, and type of defect repair (closure). All 16 infants in the EFP group received EHM feedings, whereas only 10 infants (62.50%) in the TF group received EHM. This difference, although not www.advancesinneonatalcare.org
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FIGURE 1
Gastroschisis data collection sheet.
statistically significant, can be attributed to the initiation of the early EFP, which stipulates consistent use of EHM. As previously stated, complex gastroschisis patients, who reflect degree of illness, were excluded from this study. In addition, there were no other associated comorbidities noted, which may have contributed to group differences or affected the results of this study. Table 3 provides a complete overview of demographic characteristics between groups.
Primary Outcome Measures The effectiveness of interventions and positive patient outcomes is often measured by LOS. This variable, therefore, was chosen as the primary
outcome measure for this study. An independent t test was conducted to compare the difference between the 2 groups. Results indicate a statistically significance difference in the scores for LOS between the TF group (M = 28.25, standard deviation [SD] = 8.3467) and the early initiation feeding protocol group (M = 35.31, SD = 8.2196), t30 = −2.412, P = 0.022 two-tailed. It can be inferred that patients in the TF group had a shorter LOS, suggesting that the initiation of early enteral feedings did not reduce the length of hospitalization in the EFP group.
Secondary Outcome Measures Although the primary outcome measure did not demonstrate that the initiation of early enteral feedings
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reduced LOS, a statistically significance difference was seen in 3 of the secondary outcome measures— incidence of sepsis, the number of days from initiation of feeding to achieve full enteral intake, and the number of days from defect closure to the initial feeding. Most notably, the incidence of sepsis between the groups was statistically significant {χ2 (1, N = 32) = 4.386; P = .036}. Of those infants who became septic (n = 9), 77.8% (n = 7) were in the TF group, whereas only 22% (n = 2) were in the EFP group (Table 4). Likewise, there was a statistically significant difference in the scores for the number of days from the initiation of feedings to achieve full enteral intake between the TF group (M = 11.63, SD = 8.397) and the EFP group (M = 19.38, SD = 6.888), t30= 2.854, P = .008, and the number of days from primary closure of the defect to the initial feeding between the TF group (M = 9.75, SD = 5.905) versus the EFP group (M = 6.31, SD = 1.991), t18.4= 2.207, P = .009. These finding are not surprising as they are consistent with the nutritional management guidelines
FIGURE 2
Sample traditional feeding (TF) group and early enteral feeding protocol (EFP) group.
TABLE 3. Demographic Characteristics of Neonatal Gastroschisis Patients (N = 32)a TF Group (n = 16)
EFP Group (n = 16)
Mean (SD)
Median
Range
Mean (SD)
Median
Range
Gestational age (d/wk)
257 (7.05) 36 5/7
256 36 4/7
247-274 35 2/7-39 1/7
260 (6.26) 37 1/7
260 37 1/7
245-273 35 0/7-39 0/7
Maternal age
22 (4.39)
20
15-30
22 (5.09)
21
17-32
TF Group
EFP Group
Frequency
%
Frequency
%
P
6 10
37.50% 62.50%
4 12
25.00% 75.00%
0.445
3 12 1
18.75% 75.00% 6.25%
4 12 0
25.00% 75.00% 0.00%
0.565
10 6
62.50% 37.50%
8 8
50.00% 50.00%
0.193
Primary
14
87.50%
13
81.25%
0.595
Silo
2
12.50%
3
18.75%
10 6
62.50% 37.50%
16 0
100% 0.00%
Sex Female Male Race/ethnicity African American Caucasian Mixed race Mode of delivery Vaginal Cesarean section Type of closure
Type of feeding EHM Formula
0.150
All infants in the EFP group received EHM as established by the new feeding protocol. Cross table data were run for demographics for group assignment. There were no statistically significant differences found. Groups were homogeneous. Abbreviations: EFP, early enteral feeding protocol; EHM, expressed human milk; TF, traditional feeding.
a
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TABLE 4. Differences Between Groups for Incidence of Sepsis Traditional Feeding Group (n = 16)
Early Enteral Feeding Group (n = 16)
df
χ2
Yes
7 (43.8%)
2 (12.5%)
1
4.386
No
9 (56.2%)
14 (87.5%)
Acquired Infection
P .036
a
Chi-square test, α ≤ 0.05
a
established in the early EFP, which include early initiation of enteral feedings as well as a standardized rate for feeding advancement. Measures for which there were no statistically significant differences found between the groups include the number of days from birth to achieve full enteral feedings, total number of days on TPN, and peak direct bilirubin levels (Table 5). A Pearson product-moment correlation coefficient was computed to assess the relationship between the length of stay and the initiation of early enteral feedings. There was no statistically significant correlation between the 2 variables, r = 0.63, N = 32, P = .732. There was, however, a robust positive correlation between several of the secondary outcome measures— the number of days to achieve full feedings and the LOS, the total number of days receiving TPN and the LOS, and the total number of days receiving TPN and the number of days to achieve full feedings. These findings suggest that the time to achieve full enteral feedings, with subsequent cessation of TPN, significantly impacts LOS (see Table 6 for complete data analysis information).
DISCUSSION Because of the high incidence of morbidity associated with this defect, the team was particularly interested
in the length of hospitalization, which must be considered when examining patient outcomes and overall cost of care. The selection of LOS as the primary variable is also consistent with the findings of similar studies, which infer that the initiation of early enteral feedings in postoperative patients with gastroschisis is associated with more favorable outcomes.3,6,7,13 Nutritional management of patients with gastroschisis adhered to these new guidelines during the 3 years following the implementation of the early initiation feeding protocol. Over time, the initiation of the protocol became second nature and the team believed that progress was being made. It was felt that the group had developed an evidence-based practice model that could be shared with other healthcare providers who care for these types of patients. Unlike results reported by other researchers, the findings of this study did not indicate a reduction in LOS with the initiation of the early EFP.3,6,7 However, it is important to note that the mean LOS, 35 days in the EFP group, was less than the reported national mean of 41 days.4 In addition, consideration must be given to the fact that no other study included the initiation of early enteral feedings in combination with a standardized feeding advancement protocol, as used in this study, to examine outcomes of patients with gastroschisis. A statistically and clinically significant finding of this study was the reduction of the incidence of sepsis in
TABLE 5. Differences Between Groups for Primary and Secondary Outcome Measures TF Group (n = 16) Mean (SD)
Variables
Median
EFP Group (n = 16) Mean (SD)
Median
t −2.412
df
P*
30
.022*
28.250 (±8.3467)
31.500
35.313 (±8.219)
33.500
# days from primary closure to initiation of feeds
9.75 (±5.905)
9.50
6.31 (±1.911)
6.00
2.207
# days from birth to achieve full feedings
22.375 (±7.990)
22.00
27.188 (±1.844)
26.00
−1.844
30
.075
# days from first feeding to full intake
11.63 (±8.397)
9.00
19.38 (±6.888)
18.00
−2.854
30
.008*
# days on TPN
21.56 (±8.107)
23.50
26.25 (±7.000)
25.00
−1.751
30
.090
−1.032
30
.310
Length of hospital stay
Direct bilirubin levels
1.250 (±0.9953)
1.050
1.631 (±1.09)
1.250
18.366 .009*
*Independent t test, α ≤ 0.05. Abbreviations: EFP, early enteral feeding protocol; TF, traditional feeding; TPN, total parenteral nutrition.
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TABLE 6. Results of the Pearson Correlation Coefficienta Primary Outcome Variable Length of stay # days 0 to initial feeding
0.063 (NS)
Secondary outcome variables Length of stay
# days to full feedings
Length of stay
1.00
# days to full feedings
0.895b
1.00
Total # days TPN
0.917b
0.942b
Total # days TPN
1.00
Listwise, N = 32. bCorrelation is significant at the 0.01 level (two-tailed). Abbreviations: NS, not significant; TPN, total parenteral nutrition. a
the EFP group. This finding suggests that the introduction of early enteral feedings may better establish natural gut flora, diminish the inflammatory process, and decrease pathogen proliferation.16
Study Limitations There are several limitations to this study. First, this is a retrospective study that used a convenience sample and lacked randomization, thereby imposing limits to generalizability. Second, chart review occurred retrospectively of physician documentation instead of being performed in real time. The study was also conducted at a single-center site and the sample size was relatively small. In addition, enteral feedings were advanced in the TF group on the basis of individual judgment versus a standardized advancement protocol. This difference may have inadvertently contributed to the increased LOS in the
EFP group for those infants who may have tolerated more aggressive advancements of enteral intake outside of the protocol parameters. Of particular importance is a central line catheter care and maintenance policy change initiated in 2009. Although there is sufficient evidence that suggests that early enteral feeding, particularly with EHM, may increase immune function, this change may have influenced the decrease in incidence of sepsis for the EFP group.
RECOMMENDATIONS AND IMPLICATIONS FOR FUTURE PRACTICE The findings of this study did not support the hypothesized benefits of an early EFP to reduce LOS but suggest that the time to achieve full enteral feedings significantly impacts the length of
Summary of Recommendations for Practice and Research What we know:
• Lack of consistency exists within and among clinical practices regarding the timing of initiation of enteral feedings for patients with gastroschisis • No best practices have been established for the optimal nutritional management of patients with gastroschisis • Time to achieve full enteral intake has a significant impact on LOS for patients with gastroschisis
What needs to be studied:
• Large multicenter randomized control trials to determine best practices for the nutritional management of patients with gastroschisis • Outcomes of infants who are fed human milk versus formula postsurgical gastroschisis repair
What we can do today:
• Establish consistent nutritional management of patients with gastroschisis within clinical groups • Incorporate early enteral feedings feeding strategies postgastroschisis repair • Consider more aggressive advancement of enteral feeding volumes to achieve quicker full enteral intake in patients with gastroschisis www.advancesinneonatalcare.org
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Effects of Early Enteral Feedings
hospitalization. Because of the relatively low incidence of gastroschisis, a large multicenter randomized controlled trial should be conducted to increase generalizability and statistical strength. It is also important to recognize that the decreased incidence of sepsis found in the early EFP group infers that early enteral feedings may offer the advantage of increased immune function. Therefore, consideration for future studies may warrant incorporating strategies that combine early enteral feeding initiatives with interventions that allow the clinician to more rapidly advance feedings to achieve quicker onset of full intake.
6. 7. 8. 9.
10. 11. 12.
References 1. Holland AJ, Walker K, Badawi N. Gastroschisis: an update. Pediatr Surg Int. 2010;26(8):871-878. doi: 10.1007/s00383-010-2679-1. 2. Centers for Disease Control and Prevention. (CDC). Data and statistics in the United States. http://www.cdc.gov/ncbddd/birthdefects/ data.html. Published 2013. Accessed March 12, 2014. 3. Kassa A, Lilja HE. Predictors of postnatal outcome in neonates with gastroschisis. J Pediatr Surg. 2011;46:2108-2114. doi: 10.1016/j. jpedsurg.2011.07.012. 4. Centers for Disease Control and Prevention (CDC). Hospital stays, hospital charges, and in-hospital deaths among infants with selected birth defects—United States, 2003. MMWR Morb Mortal Wkly Rep. 2007;56(2):25-29. 5. Walter-Nicolet E, Rousseau V, Kieffer F, et al. Neonatal outcome of gastroschisis is mainly influenced by nutritional management. J
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Pediatr Gastroenterol Nutr. 2009 ; 48 : 612-617. doi: 10.1097/ MPG.0b013e31818c5281. Kohler JA, Perkins AM, Bass WT. Human milk versus formula after gastroschisis repair: effects on time to full feeds and time to discharge. J Perinatol. 2013;33(8):627-630. doi: 10.1038/jp.2013.27. Aljahdali A, Mohajerani N, Skarsgard E, et al. Effect of timing of enteral feeding on outcome in gastroschisis. J Pediatr Surg. 2013;48:971-976. doi: 10.1016/j.pedsurg.2013.02.014. Bradnock TJ, Marven S, Owen A, et al. Gastroschisis: one year outcomes from national cohort study. BMJ. 2011;343:d6749. doi: 10.1136/ bmj.d6749. Clark RH, Walker MW, Gauderer MWL. Prevalence of gastroschisis and association hospital time continue to rise in neonates who are admitted for intensive care. J Pediatr Surg. 2009;42(5):815-818. doi: 1016/j.pedsurg.2009.02.018. Williams T, Butler R, Sundem T. Management of the infant with gastroschisis: a comprehensive review of the literature. Newborn Infant Nurs Rev. 2003;3(2):55-63. doi: 10.1053/nbin.2003.36106. Ekingen G, Ceran C, Haulk-Guvenc B, Tuzlaci A, Kahraman H. Early enteral feeding in newborn surgical patients. Nutr. 2005;21:142-146. doi:10.1016/j.nut.2004.10.003. Emil S, Canvasser N, Chen T, Friedrich E, Su W. Contemporary 2-year outcomes of complex gastroschisis. J Pediatr Surg. 2012;47(8):15211528. doi: 10.1016/j.jpedsurg.2011.12.023. Singh SJ, Fraser A, Leditschke JF, et al. Gastroschisis: determinants of neonatal outcome. Pediatr Surg Int. 2003;19:260-265. doi: 10.1007/ s00383-002-0886-0. National Birth Defects Prevention Network. Birth defects state profile. http://www.nbdpn.org/docs/LA_2010_C.pdf. Published 2010. Accessed February 1, 2014. Polit DE, Beck CT. Designing a quantitative analysis strategy: from data collection to interpretation. In: Nursing Research Generating and Assessing Evidence for Nursing Practice. 8th ed. Philadelphia, PA: Lippincott; 2008:642-663. Sharma R, Tepas JJ, Hudak ML, et al. Neonatal gut injury and infection rate: impact of surgical debridement on outcome. Pediatr Surg Int. 2005;21:977-982. doi: 10.1097/MPG.0b013e31818c5281.
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Please consider submitting a manuscript related to your neonatal clinical practice. Section Overview: Manuscripts submitted for this section contain information that is fundamental to neonatal nursing practice. The reader will gain knowledge from the article that enriches and expands clinical knowledge and practice. We welcome policy changes, critical review of the literature, and examples of clinical excellence, overall these manuscripts capture the essence neonatal clinical care. Examples of these types of articles are: • Concept analysis of ideas central to neonatal nursing • Clinical excellence related to specific problems • Descriptions of essential nursing care strategies for specific diagnosis from the novice to the expert, or targeted to a specific audience such as the new staff nurse or the advanced practice nurse • Care practices (or bundles) based on evidence-based interventions • Neonatal assessment processes • Neonatal concepts that pertain to all levels of nursing For more details on manuscript submissions. Please see the author guidelines for Advances in Neonatal Care available at http://edmgr.ovid.com/anc/accounts/ifauth.htm Please contact Ksenia Zukowsky, PhD, APRN, NNP-BC, or Linda Ikuta, RN, MN, CCNS, PHN, Section Editors at [email protected] or [email protected] for questions.
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