Systemic hypothermia induced within 10 hours after birth improved neurological outcome in newborns with hypoxic-ischemic encephalopathy.
OBJECTIVE
To evaluate the efficacy of systemic hypothermia when applied within 10 hours after birth to neonates with hypoxic-ischemic encephalopathy (HIE).


METHODS
Ninety-three term infants with moderate-to-severe HIE were randomly assigned to either systemic hypothermia (n = 46) or conventional treatment (n = 47). Hypothermia was induced within 10 hours after birth, decreasing rectal temperature to 33.5°C for 72 hours, followed by slow rewarming to 36.5°C. Neurodevelopmental outcome was assessed at 18 months old. The primary outcome was death or moderate-to-severe disability.


RESULTS
Outcome data were available for 82 infants. Death or moderate-to-severe disability occurred in 21 of 44 infants (47.7%) in the control group and in 7 of 38 infants (18.4%) in the hypothermia group (P = 0.01) at 18 months. The primary outcome was not different whether hypothermia was started within 6 hours or 6 to 10 hours after birth. Subgroup analysis suggested that systemic hypothermia improved long-term outcome only in infants with moderate HIE (P = 0.009), but not in those with severe HIE. No severe hypothermia-related adverse events were observed.


CONCLUSIONS
Systemic hypothermia reduced the risk of disability in infants with moderate HIE, in accordance with earlier studies. Hypothermia was induced within 6 hours in most infants, but delaying the onset to 6 to 10 hours after birth did not negatively affect primary outcome. Further studies with a large number of patients are needed to confirm that delayed cooling is equally effective.
Li
Tongchuan
T
Department of Pediatrics, Third Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Xu
Falin
F
Cheng
Xiuyong
X
Guo
Xiaoyan
X
Ji
Ling
L
Zhang
Zhan
Z
Wang
Xiaoyang
X
Blomgren
Klas
K
Simbruner
George
G
Zhu
Changlian
C
D002675:Child, Preschool; D016638:Critical Illness / Q000628:therapy*; D002658:Developmental Disabilities / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007036:Hypothermia, Induced / Q000379:methods*; D020925:Hypoxia-Ischemia, Brain / Q000628:therapy*; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal; D008297:Male; D011379:Prognosis; D012189:Retrospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D047929:Term Birth; D013997:Time Factors; D016896:Treatment Outcome