Background and characteristics of infants who underwent the 18-month medical check-up
| Characteristic | OLB6378 administration group (n=102) | Placebo administration group (n=105) | P value |
| At enrolment | |||
| Gestational age, weeks | 28.7±3.1 | 28.4±3.0 | 0.568* |
| Birth weight, g | 1036±289 | 994±283 | 0.297* |
| Light-for-dates, n (%) | 35 (34) | 41 (39) | 0.564† |
| Head circumference at birth, cm | 25.5±2.6 | 25.6±2.7 | 0.773* |
| Use of antenatal steroids, n (%) | 37 (36) | 49 (47) | 0.158† |
| Caesarean section delivery, n (%) | 47 (46) | 85 (81) | <0.001† |
| Male sex, n (%) | 60 (59) | 58 (55) | 0.674† |
| Apgar score at 1 min | 6.0 (4.0, 8.0) | 5.0 (3.0, 7.0) | 0.003‡ |
| Apgar score at 5 min | 8.0 (8.0, 9.0) | 7.0 (6.0, 9.0) | 0.001‡ |
| Respiratory distress syndrome, n (%) | 68 (67) | 68 (65) | 0.769† |
| Chronic lung disease, n (%) | 56 (55) | 49 (47) | 0.267† |
| Intraventricular haemorrhage, n (%) | 10 (10) | 23 (22) | 0.022† |
| Grade III or IV, n (%) | 2 (2) | 3 (3) | 1.000† |
| Periventricular leukomalacia, n (%) | 3 (3) | 5 (5) | 0.721† |
| Late-onset sepsis, n (%) | 6 (6) | 12 (11) | 0.218† |
| Use of total parenteral nutrition, n (%) | 83 (81) | 94 (90) | 0.115† |
| Treatment for retinopathy of prematurity, n (%) | 15 (15) | 21 (20) | 0.365† |
| Age at enteral feeding exceeding 100 mL/kg/day, days | 11.0 (9.0, 17.0) | 12.0 (9.5, 16.0) | 0.654‡ |
| Infants who achieved it by 21 days of age, n (%) | 80 (78) | 91 (87) | 0.143† |
| Infants who achieved it by 21 days of age, days | 10.0 (8.0, 13.0) | 11.0 (9.0, 14.0) | 0.032‡ |
| At the 18-month medical check-up | |||
| Age, years | 1.71±0.16 | 1.71±0.15 | 0.686* |
| Corrected age, years | 1.51±0.17 | 1.51±0.13 | 0.943* |
Values are expressed as mean±SD, median (first quartile, third quartile) or number (frequency).
*Student’s t-test.
†Fisher’s exact test.
‡Mann-Withney U test.