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.