Table 1.
Baseline characteristics of children enrolled in the trial, by randomization group
| Characteristic | Group A treatment, 3 months (n = 123) |
Group B placebo (n = 124) |
Group C treatment, 6 months (n = 41) |
|||
|---|---|---|---|---|---|---|
| N | % | n | % | n | % | |
| Sex | ||||||
| Male | 72 | 58.5 | 81 | 65.3 | 26 | 63.4 |
| Female | 51 | 41.5 | 43 | 34.7 | 15 | 36.6 |
| Age at baseline (years) | ||||||
| 1–2 | 63 | 51.2 | 46 | 37.1 | 16 | 39.0 |
| 3–4 | 41 | 33.3 | 50 | 40.3 | 12 | 29.3 |
| 5–6 | 19 | 15.5 | 28 | 22.6 | 13 | 31.7 |
| Mean ± SD | 3.6 ± 1.6 | 3.7 ± 1.5 | 3.8 ± 1.7 | |||
| Ethnic group | ||||||
| Caucasian | 104 | 84.5 | 102 | 82.3 | 36 | 87.8 |
| Any other | 19 | 15.5 | 22 | 17.7 | 5 | 12.2 |
| Residence | ||||||
| Milan City | 59 | 48.0 | 72 | 58.1 | 26 | 63.4 |
| Outside Milan | 64 | 52.0 | 52 | 41.9 | 15 | 36.6 |
| Education (parents)a | ||||||
| Primary/secondary | 9 | 7.3 | 9 | 7.4 | 4 | 9.8 |
| High school degree (at least one parent) | 60 | 48.8 | 43 | 35.2 | 14 | 34.1 |
| University degree (at least one parent) | 54 | 43.9 | 70 | 57.4 | 23 | 56.1 |
| Passive smoking (from parents) | ||||||
| No | 81 | 66.4 | 89 | 71.8 | 26 | 63.4 |
| Yes (at least one parent) | 41 | 33.6 | 35 | 28.2 | 15 | 36.6 |
| No. of siblings | ||||||
| 0 | 28 | 22.8 | 31 | 25.0 | 13 | 31.7 |
| 1 | 75 | 61.0 | 73 | 58.9 | 20 | 48.8 |
| 2+ | 20 | 16.3 | 20 | 16.1 | 8 | 19.5 |
| Attending nursery/primary school | ||||||
| No | 18 | 14.6 | 9 | 7.3 | 5 | 12.2 |
| Yes | 105 | 85.4 | 115 | 92.7 | 36 | 87.8 |
| History of atopy | ||||||
| No | 96 | 78.1 | 95 | 76.6 | 32 | 78.1 |
| Yes | 27 | 21.9 | 29 | 23.4 | 9 | 21.9 |
| History of recurrent wheezing | ||||||
| No | 105 | 85.4 | 103 | 83.1 | 35 | 85.4 |
| Yes | 18 | 14.6 | 21 | 16.9 | 6 | 14.6 |
No statistically significant differences were detected between groups
aThe sums may not add up to the total because of missing values