Table 2.
Outcomes at 18–22 months of age for infants
| Hypothermia (n=202 or n=114 who survived) | Control (n=206 or n=138 who survived) | Risk ratio (95% CI) | p value | ||
|---|---|---|---|---|---|
| Primary outcome | |||||
| Death or moderate or severe disability | 98/195 (50%) | 94/199 (47%) | 1·06 (0·87–1·30) | 0·55 | |
| Predefined secondary outcomes | |||||
| Death up until 18 months | 84/198 (42%) | 63/201 (31%) | 1·35 (1·04–1·76) | 0·022 | |
| Severe disability among those who survived | 14/112 (13%) | 28/136 (21%) | 0·61 (0·34–1·11) | 0·10 | |
| Microcephaly | 33/110 (30%) | 37/135 (27%) | 1·09 (0·74–1·62) | 0·66 | |
| Exploratory outcomes among those who survived | |||||
| Moderate disability | 0/111 | 3/135 (2%) | .. | .. | |
| Survival without neurodisability* | 47/111 (42%) | 47/136 (35%) | 1·23 (0·89–1·68) | .. | |
| Bayley cognitive composite score | |||||
| ≥85 | 72/108 (67%) | 87/133 (65%) | 1 (ref) | .. | |
| 70–84 | 25/108 (23%) | 22/133 (17%) | 1·28 (0·77–2·11) | .. | |
| <70 | 11/108 (10%) | 24/133 (18%) | 0·61 (0·32–1·18) | .. | |
| Bayley motor composite score | |||||
| ≥85 | 91/108 (84%) | 100/133 (75%) | 1 (ref) | .. | |
| 70–84 | 6/108 (6%) | 7/133 (5%) | 0·95 (0·33–2·72) | .. | |
| <70 | 11/108 (10%) | 26/133 (20%) | 0·52 (0·27–1·00) | .. | |
| Bayley language composite score | |||||
| ≥85 | 61/108 (56%) | 59/133 (44%) | 1 (ref) | .. | |
| 70–84 | 29/108 (27%) | 47/133 (35%) | 0·73 (0·50–1·05) | .. | |
| <70 | 18/108 (17%) | 27/133 (20%) | 0·73 (0·43–1·21) | .. | |
| Persistent seizure disorder | 3/111 (3%) | 9/133 (7%) | 0·40 (0·11–1·44) | .. | |
| Disabling cerebral palsy† | 12/111 (11%) | 28/136 (21%) | 0·53 (0·28–0·98) | .. | |
| GMFCS, median (IQR) | 0 (0 to 0) | 0 (0 to 1) | 0 | .. | |
| Blindness‡ | 5/111 (5%) | 10/135 (7%) | 0·61 (0·21–1·72) | .. | |
| Hearing impairment‡ | 3/112 (3%) | 6/136 (4%) | 0·60 (0·16–2·37) | .. | |
| Severe microcephaly§ | 19/110 (17%) | 23/135 (17%) | 1·01 (0·58–1·76) | .. | |
| Wasting¶ | 41/110 (37%) | 48/134 (36%) | 1·04 (0·75–1·45) | .. | |
| Stunting¶ | 61/111 (55%) | 66/133 (50%) | 1·11 (0·87–1·41) | .. | |
Data are number of patients (%), unless otherwise indicated. Percentages are based on the number infants for whom data were available. GMFCS=gross motor function classification system. Median difference (95% CI) in GMFCS score between groups reported.
Survival without neurodisability indicates infants with Bayley compositive cognitive, motor, and language scores of more than 84, a GMFCS score of 0, and no persistent seizure disorder or hearing or visual loss.
Infants with cerebral palsy who had a GMFCS score of 2 or more.
All infants with blindness or a hearing impairment also had a Bayley Scales of Infant and Toddler Development (third edition) cognitive composite score of less than 70 or GMFCS score of more than 3.
The term microcephaly indicates a head circumference of smaller than 2 SDs less than the mean for their age, and severe microcephaly indicates a head circumference of smaller than 3 SDs less than the mean for their age, based on WHO child growth charts in 2009.17
The term wasting indicates a weight less than the fifth centile for their age and stunting indicates a height (length) less than the fifth centile for their age, based on WHO child growth charts in 2009.17