Table 2 Baseline characteristics and ear assessments between enrolment and randomisation (including day of enrolment and day of randomisation)
Amoxicillin | Placebo | |
|---|---|---|
N = 52 | N = 51 | |
Mean age (years) of mothers | 24.5 (N = 52) | 23.3 (N = 50) |
Mean gestation (weeks) | 38.3 (N = 43) | 38.5 (N = 46) |
Mean birth weight (gm) | 2812 (N = 51) | 3155 (N = 50) |
Male | 24 (46%) | 30 (59%) |
Enrolment to randomisation (inclusive) | ||
Mean age (mo) at enrolment | 4.2 | 3.2 |
Mean duration to randomisation (months) | 1.6 | 1.8 |
Number of study visits | 155 | 166 |
Mean visits per child | 2.5 | 2.6 |
Number (%) of examinations with the following worst ear status(enrolment to randomisation, inclusive) | ||
N = 155 | N = 166 | |
Normal | 18 (12%) | 19 (11%) |
Otitis media with effusion (OME) | 83 (54%) | 82 (49%) |
Acute Otitis Media (AOM) without perforation (AOMwoP) | 41 (26%) | 44 (26%) |
AOM with perforation (AOMwiP) | 6 (4%) | 10 (6%) |
Dry perforation | 1 | 1 |
Chronic Suppurative Otitis Media (CSOM) | 0 | 2 |
Any suppurative OM†| 47 (30%) | 56 (34%) |
Any perforation‡ | 7 (5%) | 13 (8%) |