Acta PRdiatr Scand 80: 4 18-422, 199 1
Acute Otitis Media in Early Infancy Recurrence and Prophylaxis G. FAUSKIN From the Departments of Pediatrics, Harbor UCLA Medical Center, Torrance, California, and University of California, San Diego, USA
ABSTRACT. Fauskin, G. (Departments of Pediatrics, Harbor UCLA Medical Center, Torrance, California, and University of California, San Diego, USA). Acute otitis media in early infancy. Recurrence and prophylaxis. Acta Paediatr Scand 80: 418, 1991.
During a four-year period, two groups of patients were observed for recurrences of bouts of acute otitis media (AOM) after initial episodes of AOM in early infancy. Of 19 infants with a first bout of AOM before 3 months of age, all had at least one recurrence within eight months, of them 15 (79 %) within four months. All members of a second group of 37 infants with two bouts of AOM before 12 months of age had a third bout within 14 months, and 28 of them (76%) had a recurrence within four months. During the ensuing two years (phase two), a group of 6 infants with one bout of AOM before 3 months of age (group one) and a group of 25 infants with two bouts of AOM before 12 months of age (group two) were treated for four months with 25 mg/kg/day aminopenicillin as a single oral daily dose. There were no episodes of AOM in these infants during the prophylactic period. During a third phase lasting two years, patients were assigned to treatment or no treatment regimens for four-month periods. Patients in treatment regimens received aminopenicillin or erythromycin ethylsuccinate-sulfamethoxazole(EES-SMZ) once daily. In infants with one bout of AOM before 3 months (Group 1) there were seven bouts of AOM in 9 untreated vs. one bout in 13 treated patients. In the group of infants with two bouts of AOM before 12 months (Group 2), 13 untreated infants had six bouts of AOM vs. no bouts in 19 treated patients. Key words: otitis media, em& infancy, prophylaxis, aminopeniciffin, erythromycin ethylsuccinate, sulfamethoxazole.
Children experiencing their first bout of acute otitis media (AOM) within the first year of life have been shown to be four times as likely to be otitis-prone as children whose first bout is experienced after the first year of life (1). A study of Swedish children showed an even more impressive ratio of 14: 1 (2). In a group of American Indians with reduced tympanic membrane mobility on the first or second day of life, a two-fold increase in incidence of AOM and middle ear effusion (MEE) was shown in a seven-month follow-up compared to the incidence in newborn infants with complete mobility (3). Since the report by Ensign who used sulfa (4), other agents have also been shown to be highly effective in reducing the frequency of episodes of AOM in otitis-prone children. Agents used include ampicillin ( 5 ) , sulfisoxazole with pneumococcal vaccine (6), sulfisoxazole alone (6-1 l), trimethoprim-sulfamethoxazole (12), sulfamethoxazole (13), erythromycin ethylsuccinate ( 14), and aminopenicillin (1 5). The aims of this study were to identify specifically the frequency and timing of recurrent otitis episodes after initial episodes of AOM experienced in early infancy, and to evaluate the effectiveness of antibiotic prophylaxis in a matched group of infants, in reducing the anticipated recurrent episodes.
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MATERIALS AND METHODS The patients were drawn from a general pediatric practice in two suburban southern California communities. The patients were preponderantly from middle-class Caucasian families. Phase one (Observation period). During the four-year period from July 1979 through June 1983, study patients included all infants diagnosed with one bout of AOM before 3 months of age (Group 1) and all infants with two bouts of AOM before 12 months of age (Group 2). All infants were followed for at least one year to record the next bout of AOM (second or third, respective!y). Phase two (Prophylactic period). During the ensuing two-year period from July 1983 through June 1985, patients were selected on the same basis as above (1 bout of AOM before 3 months and 2 bouts of AOM before 12 months). At the end of therapy for the acute episode, the infants were entered into a four-month protocol of chemoprophylaxis consisting of a single daily dose of aminopenicillin (amoxicillin or ampicillin) of 25 mg/kg/day to a maximum of 250 mg. Monthly pneumatic otoscopic evaluation was performed. Infants were excluded from this phase of the study for failure to present for monthly evaluation, parental decision against chemoprophylaxis, or parental discontinuance of daily prophylaxis before the end of the fourmonth period. Phase three (Controlled study period). The first two phases were conducted in Torrance, California, and phase three in El Cajon, California. During the calendar years 1987 and 1988, infants were enrolled in phase three on the basis of the same criteria as in phases one and two (1 AOM before to 3 months (group one) or 2 AOM before 12 months (group two)). They were assigned to treatment or no treatment groups according to the parents’ desires to give or not give antibiotic prophylaxis to the child. During this phase, prophylaxis consisted of aminopenicillin as in phase two or erythromycin ethylsuccinate-sulfamethoxazole (EES-SMZ). The agent(s) used for treatment of the most recent episode of AOM was employed for the fourmonth prophylaxis. The use of EES-SMZ for the treatment of AOM has been reported earlier (1 6, 17). The dosage used for prophylaxis with EES-SMZ was 20 mg erythromycin ethylsuccinate plus 25 mg sulfamethoxazole per kg per day in a single daily dose. Seventy-seven of 131 patients were excluded from phase three of the study, leaving 54 evaluable patients. Exclusions were made for lack of follow-up visits (at least two visits during the four-month period) or failure to complete four months prophylaxis if assigned to the treatment group. Definitions. AOM was diagnosed by pneumatic otoscopic finding of a red or yellow bulging tympanic membrane, or in younger infants, the presence of a full to bulging, opaque, immobile tympanic membrane in a child with an upper respiratory tract infection and recent onset of extreme irritability, ear discharge, vomiting and/or diarrhea. All episodes of AOM were treated with standard antibiotic therapy for a minimum of ten days or longer until both tympanic membranes were entirely normal by pneumatic otoscopy. Other factors. The role of a variety of factors known to affect AOM in early infancy (AOMEI) (18), such as breast feeding, day care, and parental smoking were not addressed in this study.
Table 1. Time between occurrence offirst and second episodes of acute otitis media (Group 1. first AOM < 3 months of age) Elapsed months
Number of patients
Cumulative number 5 8 12 15 16 17 18 19
Cumulative percentage of group 26 42 63 79 84 89 95 100
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Table 2. Time between occurrence offirst and second episodes of acute otitis media (Group 1, first AOM Q 3 months of age)
Months beween 1st and 2nd AOM
RESULTS During the first phase of this study there were 19 evaluable patients with one bout of AOM before 3 months of age (Group 1) and 37 patients with two bouts of AOM before 12 months of age (Group 2). During the observation period after the index bout of AOM, all patients experienced a second or third bout of AOM, respectively. The occurrence of second bouts in the first group is shown in detail in Tables 1 and 2. The occurrence of third bouts of AOM in the second group is shown in Tables 3 and 4. These recurrences can be seen to occur in about three-fourths of both groups within four months (79 96 and 76 Yo, respectively). In the second phase of the study, chemoprophylaxis was employed in a fourmonth period in 6 patients in group one (1 AOM before 3 months) and 25 patients in group two (2 bouts of AOM before 12 months). During the period of prophylaxis there were no bouts of AOM in either group. Results of both the observational and prophylactic phases (phases one and two) are presented in Table 5 . In phase three of this study there were 22 evaluable patients in Group 1 (first AOM before 3 months) and 32 in Group 2 (2 bouts of AOM before 12 months). In 9 patients in Group 1 who were untreated, there were seven bouts of AOM within four months; in 13 patients treated for four months with a single dose daily of
Table 3. Time between occurrence of second and third episodes of acute otitis media (Group 2, first AOM < 12 months of age) Elapsed months 1
Number of patients
12 8 7
12 20 27 28 30 35 36 37
5 6 8
2 5 1 1
Cumulative percentage of group 32 54 73 76
81 95 97 100
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Table 4. Time between occurrence of second and third episodes of acute otitis media (Group 2, two AOM < 12 months of age) 12 11
k 4 z
I I 8
1 3 1 4
Months between 2nd and 3rd AOM
antibiotic prophylaxis, there was only one bout of AOM. There were six bouts of AOM in 13 untreated patients in group 2 and no AOM in 19 treated patients. Results are presented in Table 5 . Combining the patients in phase one with the untreated patients in phase three, there were 56 bouts of AOM in 78 patients. Similarly grouping phase two patients with the treated patients in phase three, there was only one bout of AOM in 63 patients. In a review of the charts of the 77 patients excluded from phase three, two serious outcomes were found. Both were male infants whose parents were offered prophylaxis but failed in implementation. One, with a first bout of AOM at 6 weeks, expired with sudden infant death syndrome (SIDS) at 3 months. The second had AOM at 7 and 10 months, then meningococcal meningitis at 12 months. DISCUSSION Concurrent with the four-year observational phase of this report (phase one), the author was involved in a study of older children with recurrent qtitis media (ROM) Table 5 . Incidence ofAOM within 4 months of index episode ofAOM Group 1 Group 2 Groups 1&2 AOMINo. of patients AOMINo. of patients AOMINo. of patients Phase 1 (no treatment) 15/19 Phase 2 (treated) 016 Phase 3 (no treatment) 719 Phase 3 (treated) 1/13 Total no treatment 22/28 Total treated 1/19
28/37 0/25 6/13 0119 34/50 0144
43/56 013 1 13/22 1/32 56/78 1/63
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(1 5). After several years of comparing various chemoprophylactic agents, aminopenicillin was chosen as the most effective. No difference was observed in effectiveness of amoxicillin versus ampicillin. A protocol involving the use of either aminopenicillin was developed and employed over the four-year period in 11 1 children who had experienced three or more bouts of AOM in a six-month period. The change in frequency of otitis media before and during prophylaxis expressed in bouts/patient/month was 0.65 in the immediate pretreatment period to 0.01 3 during a four-month propylactic period. Phase three expanded the study to include prophylaxis with EES-SMZ after other studies had shown it to be as effective as aminopenicillin. The results of this study have led to expansion of the criteria for selection of children to receive single dose daily aminopenicillin or EES-SMZ to include infants with one bout of AOM before 3 months of age, two bouts of AOM before 12 months of age, and three bouts of AOM within six months at any age.
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1986; 25: 510-15. 15. Fauskin GN. Aminopenicillin prophylaxis of recurrent otitis media. Pediatr Infect Dis J 1987; 6: 770-71. 16. Fauskin GN. Treatment of acute otitis media. Pediatr Infect Dis J 1987; 6: 1072-73. 17. Fauskin GN. Erythromycin ethylsuccinate-sulfamethoxazole mixture vs. amoxicillin for acute otitis media. Pediatr Infect Dis J 1988; 7: 370. 18. Kero P, Piekkala P. Factors affecting the occurrence of acute otitis media during the first year of life. Acta Paediatr Scand 1987; 76: 618-23.
Submitted Dec 4, 1989. Accepted April 2, 1990 (G. F.) 1625 East Main Street, Suite 200 El Cajon, California 9202 1 USA