Comparison of clinical characteristics and incidence of NEC between oral vancomycin and the placebo groups
| Clinical features | Oral vancomycin group (n=71) | Placebo group (n=69) |
|---|---|---|
| Gestational age (weeks) | 29.6 (27.7 to 31.1) | 28.6 (27.0 to 30.1) |
| Birthweight (g) | 1180 (935 to 1350) | 1170 (939 to 1325) |
| Sex (female:male) | 35 (50):36 (50) | 29 (42):40 (58) |
| Inborn:outborn | 68 (96):3 (4) | 67 (97):2 (3) |
| Antenatal corticosteroid treatment | 50 (70) | 45 (65) |
| Mode of delivery | ||
| Vaginal | 32 (45) | 26 (38) |
| Caesarean section | 37 (52) | 42 (61) |
| Ventouse | 1 (1.5) | 1 (1) |
| Forceps | 1 (1.5) | 0 (0) |
| Apgar scores | ||
| 1 min < 3 | 12 (17) | 7 (10) |
| 5 min < 3 | 1 (1) | 1 (1) |
| First arterial blood gas after delivery | ||
| pH | 7.37 (7.29 to 7.46) | 7.36 (7.31 to 7.43) |
| Base excess | −2.5 (−6.1 to −1.0) | −2.6 (−5.4 to −0.6) |
| Temperature on admission (°C) | 36.1 (35.8 to 36.5) | 36.2 (35.6 to 36.7) |
| First venous haematocrit after delivery | 0.52 (0.47 to 0.57) | 0.51 (0.46 to 0.54) |
| Lowest mean arterial blood pressure (mm Hg) | 28 (23 to 32) | 27 (21 to 30.5) |
| Exchange transfusion | 2 (3) | 0 (0) |
| Umbilical arterial catheterisation | 42 (59) | 38 (55) |
| Umbilical venous catheterisation | 55 (77) | 59 (86) |
| Aminophylline treatment | 49 (69) | 46 (67) |
| Respiratory distress syndrome | ||
| Stage 0-2 | 45 (63) | 51 (74) |
| Stage 3-4 | 26 (37) | 18 (26) |
| Periventricular haemorrhage | ||
| Stage < 2 | 63 (89) | 57 (83) |
| Stage 3-4 | 8 (11) | 12 (17) |
| Patent ductus arteriosus | ||
| Indomethacin closure | 35 (49) | 37 (54) |
| Surgical ligation | 3 (4) | 2 (3) |
| Age started on enteral feeds (days) | 5 (3 to 9) | 6 (5 to 9) |
| Age received full enteral feeds (days) | 27 (20 to 36) | 28 (19 to 45) |
| Type of milk feeds | ||
| Breast | 12 (17) | 8 (12) |
| Formula | 28 (39) | 33 (48) |
| Mixed | 31 (44) | 28 (41) |
| Incidence of NEC1-150 | 9 (13) | 19 (28) |
| NEC stages | 25 (16 to 42) | 26 (17 to 33) |
| 0-1 | 62 (87) | 50 (72) |
| 2 | 4 (6) | 12 (17) |
| 3 | 5 (7) | 7 (11) |
| Stool culture (fungus: Gram (−): Gram (+)) | ||
| Before prophylaxis | 1 (1):2 (3):13 (18) | 2 (3):6 (9):12 (17) |
| Immediately after prophylaxis | 8 (11):10 (14):1 (1) | 9 (12):12 (17):2 (3) |
| Four weeks after prophylaxis | 4 (6):16 (23):2 (3) | 1 (1):14 (20):0 (0) |
| Duration of mechanical ventilation (days) | 6 (2 to 14) | 8 (3 to 24) |
| Duration of O2 dependency (days) | 10 (3 to 29) | 13.5 (4.5 to 50.5) |
| Duration of hospital stay (days) | 84 (55 to 112) | 90.5 (66 to 126) |
| Died | 11 (15) | 13 (19) |
Continuous variables are expressed in median (interquartile ranges) and proportions in number of patients (%).
↵1-150 p<0.05.