Demographic and clinical characteristics of the study infants
| Variables | Probiotic (n=200) | Placebo (n=200) |
|---|---|---|
| Gestational age, weeks* | 28.2±2.4 | 27.9±2.5 |
| Birth weight, g* | 1071±274 | 1048±298 |
| Male† | 108 (54) | 98 (49) |
| Caesarean† | 163 (81.5) | 152 (76) |
| Apgar 5, min‡ | 8 (5–9) | 8 (5–9) |
| Prenatal steroid† | 141 (70.5) | 154 (77) |
| PPROM† | 44 (22) | 40 (20) |
| Chorioamnionitis† | 6 (3) | 4 (2) |
| SGA† | 17 (8.5) | 16 (8) |
| Asphyxia† | 4 (2) | 10 (5) |
| PDA requiring ibuprofen treatment† | 61 (30.5) | 73 (36.5) |
| Umbilical venous catheter, days‡ | 5 (2–10) | 5 (1–10) |
| Intermittent mandatory ventilation, days‡ | 3 (1–32) | 3 (1–40) |
| Duration of antibiotic treatment, days‡ | 7 (0–14) | 9 (0–15) |
| Age onset of NEC, days‡ | 25 (14–41) | 19 (14–48) |
| Nutrition | ||
| Age at start of enteral feeds, day‡ | 1 (1–5) | 1 (1–5) |
| Duration of TPN, days‡ | 7 (5–53) | 8 (5–45) |
| Exclusive breast milk feeding† | 34 (17) | 26 (13) |
| Premature infant formula† | 32 (16) | 22 (11) |
| Mixed (breast milk and formula) feeding† | 134 (67) | 152 (76) |
*Values are given as mean±SD.
†Values are given as percentage.
‡Values are given median and range.
None of the differences were statistically significant (p>0.05) except duration of TPN (p=0.048).
NEC, necrotising enterocolitis; PDA, patent ductus arteriosus; PPROM, preterm premature rupture of membranes; SGA, small for gestational age; TPN, total parenteral nutrition.