Characteristics of study subjects
| Hypothermia group, n=73 | Control group, n=63 | p Value | |
|---|---|---|---|
| Maternal characteristics | |||
| Maternal age, mean±SD (years) | 26.5±5.2 | 26.9±6.3 | 0.67 |
| Race, n (%) | 0.30 | ||
| Black | 22 (30%) | 20 (32%) | |
| White | 31 (42%) | 19 (30%) | |
| Other | 20 (27%) | 24 (38%) | |
| Complications of pregnancy, n (%) | |||
| Chronic hypertension | 8 (11%) | 10 (16%) | 0.45 |
| Antepartum haemorrhage | 6 (8%) | 13 (21%) | 0.05 |
| Intrapartum complications, n (%) | |||
| FHR decelerations | 54 (74%) | 51 (82%) | 0.30 |
| Cord prolapse | 20 (27%) | 11 (17%) | 0.22 |
| Uterine rupture | 11 (15%) | 8 (13%) | 0.81 |
| Maternal fever | 12 (16%) | 4 (6%) | 0.11 |
| Shoulder dystocia | 8 (11%) | 6 (10%) | 0.79 |
| Maternal haemorrhage | 4 (5%) | 5 (8%) | 0.73 |
| Emergency caesarean delivery, n (%) | 48 (66%) | 50 (79%) | 0.09 |
| Neonatal characteristics | |||
| Gestational age, mean±SD (weeks) | 39.1±1.5 | 38.6±1.6 | 0.08 |
| Age at randomisation, mean±SD (h) | 4.3±1.3 | 4.4±1.3 | 0.58 |
| Outborn status, n (%) | 33 (45%) | 30 (48%) | 0.86 |
| Apgar score <5, n (%) | |||
| At 5 min | 64 (89%) | 57 (90%) | 0.79 |
| At 10 min | 56 (81%) | 43 (75%) | 0.51 |
| Birth weight, mean±SD (g) | 3328±557 | 3376±677 | 0.65 |
| Head circumference, mean±SD (cm) | 34.3±1.5 | 34.1±1.7 | 0.62 |
| Male sex, n (%) | 36 (49%) | 36 (57%) | 0.39 |
| Intubation in delivery room, n (%) | 70 (96%) | 59 (94%) | 0.70 |
| Cord pH, mean±SD | 6.9±0.2 | 6.9±0.2 | 0.41 |
| Base deficit, mean±SD (mmol/l) | 17.8±5.9 | 18.8±8.9 | 0.58 |
| Moderate encephalopathy, n (%) | 54 (75%) | 40 (63%) | 0.19 |
| Severe encephalopathy, n (%) | 18 (25%) | 23 (37%) | |
| Seizures | |||
| At randomisation, n (%) | 31 (42%) | 32 (51%) | 0.39 |
| At any time, n (%) | 40 (55%) | 43 (68%) | 0.12 |
| Anticonvulsants, n (%) | |||
| At randomisation, n (%) | 31 (44%) | 28 (47%) | 0.73 |
| At any time, n (%) | 48 (68%) | 49 (79%) | 0.17 |
| Inotropic support | |||
| At randomisation, n (%) | 24 (33%) | 19 (30%) | 0.85 |
| At any time, n (%) | 40 (55%) | 35 (56%) | 1.00 |
| Deaths, n (%) | 7 (10%) | 8 (13%) | 0.59 |
| Age of death, days (mean±SD) | 62.8±80.0 | 140.9±151.0 | 0.28 |
| Age at MRI, days (mean±SD) | 14.7±10.6 | 16.0±14.0 | 0.54 |
FHR, fetal heart rate.