Selective head cooling with mild systemic hypothermia after neonatal hypoxic-ischemic encephalopathy: a multicenter randomized controlled trial in China.
OBJECTIVE
To investigate the efficacy and safety of selective head cooling with mild systemic hypothermia in hypoxic-ischemic encephalopathy (HIE) in newborn infants.


METHODS
Infants with HIE were randomly assigned to the selective head cooling or control group. Selective head cooling was initiated within 6 hours after birth to a nasopharyngeal temperature of 34 degrees+/-0.2 degrees C and rectal temperature of 34.5 degrees to 35.0 degrees C for 72 hours. Rectal temperature was maintained at 36.0 degrees to 37.5 degrees C in the control group. Neurodevelopmental outcome was assessed at 18 months of age. The primary outcome was a combined end point of death and severe disability.


RESULTS
One hundred ninety-four infants were available for analysis (100 and 94 infants in the selective head cooling and control group, respectively). For the selective head cooling and control groups, respectively, the combined outcome of death and severe disability was 31% and 49% (OR: 0.47; 95% CI: 0.26-0.84; P=.01), the mortality rate was 20% and 29% (OR:0.62; 95% CI: 0.32-1.20; P=.16), and the severe disability rate was 14% (11/80) and 28% (19/67) (OR: 0.40; 95% CI: 0.17-0.92; P=.01).


CONCLUSIONS
Selective head cooling combined with mild systemic hypothermia for 72 hours may significantly decrease the combined outcome of severe disability and death, as well as severe disability.
Zhou
Wen-hao
WH
Children's Hospital of Fudan University, Shanghai, China.
Cheng
Guo-qiang
GQ
Shao
Xiao-mei
XM
Liu
Xian-zhi
XZ
Shan
Ruo-bing
RB
Zhuang
De-yi
DY
Zhou
Cong-le
CL
Du
Li-zhong
LZ
Cao
Yun
Y
Yang
Qun
Q
Wang
Lai-shuan
LS
D002681:China; D005260:Female; D006257:Head; D006801:Humans; D007036:Hypothermia, Induced / Q000379:methods*; D020925:Hypoxia-Ischemia, Brain / Q000628:therapy*; D007231:Infant, Newborn; D008297:Male; D016037:Single-Blind Method