Table 4.
Main demographic characteristics of the infants and children recruited in the pilot trial (n = 61), and main outcomes of the study.
| Characteristic | Sex | n | Mean ± SD or Median * | p-Value |
|---|---|---|---|---|
| Age (Years) and Gender | 3.31 ± 1.7 | |||
| <3 years (n = 30) | Males | 16 | ||
| Females | 14 | |||
| ≥3 years (n = 31) | Males | 15 | ||
| Females | 16 | |||
| Inclusion months: | ||||
| September | 7 | |||
| October | 5 | |||
| November | 6 | |||
| December | 7 | |||
| January | 6 | |||
| February | 10 | |||
| March | 9 | |||
| April | 6 | |||
| May | 3 | |||
| June | 2 | |||
| History of AOM episodes/child | ||||
| Preceding 6 months | 4 (3–4) * | <0.001 ¥ | ||
| Preceding 12 months | 5 (5–6) * | <0.001 ¥ | ||
| During the study | 0 (0–1) * |
n, number of children; * Median (25Q–75Q); ¥ Wilcoxon rank sum test paired comparison.