Table 1: Demographic data and clinical variables.
Period 1 | Period 2 | P-value | |
Control group | Treatment group | ||
No probiotics | Infloran | ||
(N = 297) | (N = 283) | ||
Patient characteristics | |||
- Median GA † (in days) (IQR 25-75%) Median GA (in weeks) (range) |
189 (167-208) | 189 (163-205) | 0.24 |
27 (23 + 6 - 29 + 5) | 27 (23+2 - 29 + 2) | ||
- Median birth weight (in g) (IQR 25-75%) | 940 (460-1256) | 870 (367-1185) | 0.16 |
- Male (%) | 181 (60.9) | 171 (60.4) | 0.90 |
- Outborn (%) | 34 (11.4) | 23 (8.1) | 0.18 |
- APGAR score at 1 min (IQR 25-75%) | 6 (4-8) | 6 (4-8) | 0.64 |
- APGAR score at 5 min (IQR 25-75%) | 8 (7-9) | 8 (7-9) | 0.75 |
Maternal characteristics/delivery | |||
- Antenatal steroids | |||
- Complete course (%) | 159 (53.5) | 174 (61.5) | 0.12 |
- Incomplete course (%) | 56 (18.9) | 65 (23) | |
- Unknown/none (%) | 11/71 (27.6) | 6/38 (15.5) | |
- ROM‡ > 18 hours prior birth (%) | 81 (27.3) | 86 (30.4) | 0.41 |
- Clinical chorioamnionitis (%) | 27 (9.1) | 27 (9.5) | 0.85 |
- Histopathological chorioamnionitis (%) | 104 (35.0) | 109 (38.5) | 0.38 |
- Antepartum haemorrhage (%) | 62 (20.9) | 69 (24.4) | 0.15 |
- Pre-eclamptictoxaemia (%) | 58 (19.5) | 55 (19.4) | 0.15 |
- Spontaneous preterm labour (%) | 190 (64.0) | 169 (59.7) | 0.20 |
- Caesarean section (%) | 211 (71.0) | 185 (65.4) | 0.14 |
- Abnormal dopplers/fetal distress/non-reassuring CTG (%) | 14 (4.7) | 16 (5.7) | 0.61 |
Feeding | |||
- Age at introduction of minimal enteral feeds (days) | |||
(median, IQR 25-75%) | 2 (1-2) | 2 (1-2) | 0.27 |
- Type of feeding at starting first minimal enteral feeds | |||
- Expressed breast milk (%) | 238 (80.1) | 236 (83.4) | 0.59 |
- Formulaor mixed (%) | 52 (17.5) | 41 (14.5) | |
- Unknown/died | 2/5 (2.4) | 1/5 (2.1) | |
Persistent ductus arteriosus requiring treatment with Ibuprofen | |||
- Persistent ductus arteriosus (%) | 60 (20.2) | 58 (20.5) | 0.93 |
†GA = Gestational Age; ‡ROM = Rupture of Membranes.