Table 1.
Baseline characteristics
| Hypothermia group (n=202) | Control group (n=206) | ||
|---|---|---|---|
| Maternal age, year | 24·5 (4·6) | 24·2 (4·6) | |
| Booked pregnancies* | 196 (97%) | 190 (92%) | |
| Gravida | |||
| 1 | 118 (58%) | 117 (57%) | |
| 2 | 55 (27%) | 54 (26%) | |
| 3 | 22 (11%) | 22 (11%) | |
| 4 | 6 (3%) | 11 (5%) | |
| 5 | 0 | 2 (0%) | |
| Data missing | 1 (0%) | 0 | |
| Parity | |||
| 0 | 71 (35%) | 69 (33%) | |
| 1 | 102 (50%) | 87 (42%) | |
| 2 | 22 (11%) | 39 (19%) | |
| 3 | 6 (3%) | 8 (4%) | |
| Data missing | 1 (0%) | 3 (1%) | |
| Complications of pregnancy (events not mutually exclusive) | |||
| Pregnancy-induced hypertension | 9 (4%) | 4 (2%) | |
| Others† | 4 (2%) | 2 (1%) | |
| Maternal pyrexia | 3 (1%) | 5 (3%) | |
| Long-term rupture of membranes >24 h | 1 (0%) | 3 (1%) | |
| Meconium-stained liquor | 60 (30%) | 50 (24%) | |
| Reduced fetal movements | 16 (8%) | 8 (4%) | |
| Fetal heart rate decelerations | 14 (7%) | 9 (4%) | |
| Funisitis | 37 (18%) | 29 (14%) | |
| Missing data | 33 (16%) | 40 (19%) | |
| Perinatal sentinel events (events not mutually exclusive) | 17 (8%) | 26 (13%) | |
| Cord prolapse | 4 (2%) | 6 (3%) | |
| Cord around neck | 2 (1%) | 6 (3%) | |
| Lengthened second stage | 2 (1%) | 9 (4%) | |
| Obstructed labour | 2 (1%) | 3 (1%) | |
| Shoulder dystocia | 1 (0%) | 0 | |
| Antepartum haemorrhage‡ | 6 (3%) | 2 (1%) | |
| Mode of delivery | |||
| Unassisted vaginal birth | 133 (66%) | 150 (73%) | |
| Instrumental delivery | 21 (10%) | 19 (9%) | |
| Elective caesarean delivery | 1 (0%) | 2 (1%) | |
| Emergency caesarean delivery | 46 (23%) | 34 (17%) | |
| Data missing | 1 (0%) | 1 (0%) | |
| Place of delivery | |||
| Born at the participating hospital | 62 (31%) | 61 (30%) | |
| Born at another hospital§ | 136 (67%) | 139 (67%) | |
| Born at home¶ | 4 (2%) | 6 (3%) | |
| Sex of neonate | |||
| Male | 132 (65%) | 135 (66%) | |
| Female | 70 (35%) | 71 (34%) | |
| Age of neonate | |||
| Gestation, weeks | 38·9 (1·3) | 39·0 (1·3) | |
| Condition at birth | |||
| Cord blood pH‖ | 6·94 (0·25) | 6·97 (0·21) | |
| Apgar score at 5 min** | 5 (4–6) | 5 (4–5) | |
| Apgar score at 10 min** | 6 (4–7) | 6 (4–7) | |
| Endotracheal ventilation at birth | 89 (44%) | 89 (43%) | |
| Missing data | 2 (1%) | 5 (2%) | |
| Infant size | |||
| Birthweight, g | 2844 (450) | 2939 (455) | |
| Birthweight <2 SD from the mean | 36 (18%) | 27 (13%) | |
| Head circumference, cm†† | 34·1 (1·5) | 34·3 (1·5) | |
| Head circumference <2 SD from the mean†† | 8 (4%) | 6 (3%) | |
| Head circumference <3 SD from the mean†† | 2 (1%) | 2 (1%) | |
| Missing data | 1 (0%) | 1 (0%) | |
| Age at admission to the cooling centre, min | 126 (55–217) | 160 (60–238) | |
| Born at the participating hospital | 31 (15–46) | 30 (18–50) | |
| Referred to the participating hospital | 180 (120–240) | 189 (139–255) | |
| Stage of encephalopathy at randomisation | |||
| Moderate encephalopathy | 161 (80%) | 167 (81%) | |
| Severe encephalopathy | 41 (20%) | 39 (19%) | |
| Rectal temperature at admission, °C | 35·7 (1·2) | 36·4 (0·7) | |
| Among infants with moderate encephalopathy | 35·8 (1·1) | 36·4 (0·7) | |
| Among infants with severe encephalopathy | 35·3 (1·4) | 36·2 (0·9) | |
| Clinical seizures at random assignment | 149 (74%) | 150 (73%) | |
Data are number of patients (%), mean (SD), or median (IQR).
Antenatal follow-up visits at the recruiting hospital or any other health-care facility.
In the hypothermia group, two infants had chronic hypertension, one had epilepsy, and one had diabetes; in the control group, one had thyroid disorder and one had diabetes.
In the hypothermia group, five had placental abruption and one had placenta previa; in the control group, one had placental abruption and one had placenta previa.
Hospitals referring the infants to the HELIX trial recruiting sites were other tertiary medical college hospitals (65 infants), secondary district hospitals (124 infants), primary care centres (44 infants), private hospitals (40 infants), and unknown (two infants).
All home deliveries occurred at the site in Dhaka, Bangladesh.
Cord pH was available in only 22 infants in the hypothermic group and 24 infants in the control group.
Apgar score at 5 min was available in only 137 infants in hypothermia group and 135 infants in the control group. Apgar score at 10 min was available in only 65 infants in the hypothermia group and 67 infants in the control group.
WHO child growth charts 2009.17