Table 2.
Baseline infant and maternal characteristics in the two formula groups including fussiness-crying, gassiness and stooling difficulty used as inclusion criteria at screening.
| Characteristic | Formula A (n = 127) | Formula B (n = 129) |
|---|---|---|
| Infant characteristic | ||
| Age (days) | 55.3 ± 15.5a | 56.6 ± 14.4 |
| Males (%) | 50.4 | 47.3 |
| Gestational age (weeks) | 38.5 ± 1.0 | 38.5 ± 1.1 |
| Cesarean section delivery (%) | 33.9 | 28.7 |
| Ethnicity (%) | ||
| Chinese | 2.4 | 0.8 |
| Filipino | 62.2 | 61.2 |
| Taiwanese | 11.0 | 13.2 |
| Thai | 24.4 | 24.8 |
| First born | 42.5 | 41.1 |
| Fussiness-crying | ||
| Often (%) | 71.7 | 76.7 |
| Very often (%) | 28.3 | 23.3 |
| Gassiness | ||
| Mild (%) | 3.1 | 3.9 |
| Moderate (%) | 40.2 | 30.2 |
| Extreme (%) | 56.7 | 65.1 |
| Stooling difficultyb | ||
| Less than 3 stools/week (% yes) | 31.5 | 24.0 |
| Hard stools (% yes) | 29.9 | 39.5 |
| large fecal mass in the rectum (% yes) | 9.4 | 14.0 |
| Maternal characteristic | ||
| Age (years) | 28.4 ± 6.0 | 28.9 ± 6.1 |
| Highest level of education (%) | ||
| Elementary/middle/high school | 25.1 | 21.7 |
| Vocational school | 26.0 | 27.1 |
| Associate/college/post graduate degree | 48.9 | 51.2 |
| Employed, full-time (%) | 51.2 | 51.2 |
Formula A, 100% partially hydrolyzed whey protein, reduced lactose and enriched in sn-2 palmitate; Formula B, α-lactalbumin-enriched with 65% intact whey protein and 35% casein, full lactose and not enriched in sn-2 palmitate.
a
Data presented as mean ± standard deviation unless otherwise noted.
b
Stooling difficulty was defined as at least one of the following 3 symptoms: Less than 3 stools/week, hard stools, and large fecal mass in the rectum (physician assessed).