Table 1. Baseline characteristics.
| Characteristic | Ibuprofen (n = 324) |
Placebo (n = 322) |
|---|---|---|
| Maternal characteristics | ||
| Mother’s ethnicity— no. (%) | ||
| White | 223 (74.6) | 223 (73.6) |
| Asian | 39 (13.0) | 45 (14.9) |
| Black | 25 (8.4) | 25 (8.3) |
| Other | 12 (4.0) | 10 (3.3) |
| Not known | 25 | 19 |
| Mother’s age— yr | 30.1±6.5 | 30.2±6.2 |
| Infant characteristics at randomization | ||
| Postnatal age (hours)* — IQR | 57.5 | 56.8 |
| (43.1, 65.6) | (43.9, 66.7) | |
| < 12 hours— no. (%) | 2 (0.6) | 2 (0.6) |
| 12 to < 24 hours— no. (%) | 15 (4.6) | 14 (4.3) |
| 24 to < 48 hours— no. (%) | 90 (27.8) | 89 (27.6) |
| 48 to < 72 hours— no. (%) | 217 (67.0) | 217 (67.4) |
| Gestational age— weeks* | 26.1±1.5 | 26.1±1.6 |
| Mode of birth— no. (%) | ||
| Vaginal birth – cephalic | 141 (43.5) | 138 (42.9) |
| Vaginal birth – breech | 50 (15.4) | 46 (14.3) |
| Caesarean section before onset of labour | 83 (25.6) | 80 (24.8) |
| Caesarean section after onset of labour | 50 (15.4) | 58 (18.0) |
| Birth weight— grams | 839.9±204.8 | 852.9±211.3 |
| Sex*— no. (%) | ||
| Male | 180 (55.6) | 175 (54.3) |
| APGAR score 5 minutes after birth— no. | 278 | 288 |
| Median (IQR) | 8.0 (6.0, 9.0) | 7.0 (6.0, 9.0) |
| Size of PDA (mm)* — IQR | 2.2 (1.9, 2.5) | 2.2 (1.9, 2.6) |
| ≥1.5 mm and <2.0 mm— no. (%) | 84 (25.9) | 82 (25.5) |
| ≥2.0 mm and <3.0 mm— no. (%) | 201 (62.0) | 201 (62.4) |
| ≥3.0 mm— no. (%) | 39 (12.0) | 39 (12.1) |
| Mode of respiratory support*— no. (%) | ||
| Invasive ventilation (by endotracheal tube) | 206 (63.6) | 204 (63.4) |
| Non-invasive respiratory support only1 | 116 (35.8) | 115 (35.7) |
| Receiving no mechanical ventilation or | ||
| pressure support2 | 2 (0.6) | 3 (0.9) |
| Receiving inotropes*— no. (%) | 44 (13.6) | 37 (11.5) |
Data are presented as mean ±SD or median and interquartile range.
*
Denotes factor used in the randomization minimization algorithm
SD denotes standard deviation and IQR interquartile range.
1
Nasal continuous positive airway pressure, nasal ventilation, humidified high flow nasal cannula therapy, or low flow oxygen ≥ 1.1L per minute.
2
In room air, low flow oxygen <1.1L per min, or ambient oxygen.