Table 2.
Acute respiratory infections during follow-up, according to the randomization group
| Group A treatment, 3 months (n = 100) | Group B placebo (n = 109) | Group C treatment, 6 months (n = 37) |
p value A vs B |
p-value A vs C |
p-value C vs B |
|
|---|---|---|---|---|---|---|
| Respiratory infections (any) | n (%) | n (%) | n (%) | |||
| No | 67 (32.0) | 38 (34.9) | 26 (70.3) | |||
| Yes | 33 (33.0) | 71 (65.1) | 11 (29.7) | < 0.0001 | 0.87 | 0.0003 |
| AOM (any) | ||||||
| No | 76 (76.0) | 60 (55.1) | 28 (75.7) | |||
| Yes | 24 (24.0) | 49 (44.9) | 9 (24.3) | 0.002 | 0.85 | 0.04 |
| Antibiotic prescription | ||||||
| No | 75 (75.0) | 54 (49.5) | 27 (73.0) | |||
| Yes | 25 (25.0) | 55 (50.5) | 10 (27.0) | 0.0002 | 0.98 | 0.02 |
| Type of infection | ||||||
| URTI, mean ± SD | 0.33 ± 0.61 | 0.65 ± 0.55 | 0.29 ± 0.28 | < 0.0001 | 0.85 | 0.0007 |
| Bacterial pharyngitis, mean ± SD | 0.10 ± 0.55 | 0.14 ± 0.66 | 0.12 ± 0.49 | 0.88 | 0.91 | 0.93 |
| AOM, mean ± SD | 0.24 ± 0.41 | 0.78 ± 0.73 | 0.25 ± 0.63 | 0.006 | 0.82 | 0.03 |
| Otorrhea, mean ± SD | 0.16 ± 0.55 | 0.22 ± 0.64 | 0.19 ± 0.72 | 0.66 | 0.88 | 0.69 |
| Wheezing, mean ± SD | 0.30 ± 0.63 | 0.27 ± 0.49 | 0.14 ± 0.54 | 0.78 | 0.06 | 0.08 |
| Socioeconomic impact | ||||||
| Days of absence from day-care, mean ± SD | 4.49 ± 1.10 | 5.10 ± 1.33 | 4.33 ± 1.09 | 0.007 | 0.79 | 0.003 |
| Working days lost by parents, mean ± SD | 1.76 ± 0.76 | 2.58 ± 0.73 | 1.88 ± 0.88 | 0.004 | 0.82 | 0.0004 |
AOM: Acute otitis media; SD: standard deviation; URTI: upper respiratory tract infection; LRTI: lower respiratory tract infection