Table 2.
Outcomes Assessed for Safety Among Neonates in the Hypothermia Groups
| Duration of Cooling | Depth of Cooling | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Neonates, No. (%) | Unadjusted RR (95 % CI) |
P Value | Adjusted RR (95% CI) |
P Value | Neonates, No. (%) | Unadjusted RR (95 % CI) |
P Value | Adjusted RR (95% CI) |
P Value | |||
| 72 h (n = 185) |
120 h (n = 179) |
33.5°C (n = 191) |
32.0°C (n = 173) |
|||||||||
| All NICU deaths | 20 (11) | 29 (16) | 1.50 (0.88–2.55) |
.14 | 1.37 (0.92–2.04) |
.12 | 22 (12) | 27 (16) | 1.35 (0.80–2.29) |
.26 | 1.24 (0.69–2.25) |
.47 |
| All in-hospital deaths or ECMO | 29 (16) | 40 (22) | 1.43 (0.93–2.19) |
.11 | 1.33 (0.96–1.83) |
.09 | 29 (15) | 40 (23) | 1.52 (0.99–2.34) |
.06 | 1.35 (0.83–2.19) |
.22 |
| All deaths within 120 h of initiation of cooling | 11 (6) | 16 (9) | 1.50 (0.72–3.15) |
.28 | 1.36 (0.75–2.48) |
.31 | 10 (5) | 17 (10) | 1.88 (0.88–3.99) |
.10 | 1.59 (0.77–3.30) |
.21 |
Abbreviations: ECMO, extracorporeal membrane oxygenation; RR, relative risk.
Results are from generalized estimating equations regression (log-binomial), adjusted for level of hypoxic ischemic encephalopathy and intracenter correlations.