Clinical study of selective head cooling with mild systemic hypothermia in neonates with hypoxic-ischemic encephalopathy

Abstract

Objective To study the safety and efficacy of selective head cooling (SHC) with mild systemic hypotherrnia in neonates with HIE. Methods Fifty-four term infants with severe neonatal HIE were randomly assigned to the head cooling group (n=27) and control group (n=27). Forty-one infants in 96 h after admission were eligible for the study(SHC group n=21, control group n=20). In SHC group, the naso-pharyngeal temperature was maintained at (34.0±0.2) ℃ and rectal temperature maintained at 34～35 ℃ for 72 h, then rewarmed spontaneously. In control group, normal rectal temperature was maintained. During the period of the study, the infants of two groups were monitored on nasopharyngeal temperature, heart rate, respiratory rate,transcutaneous arterial oxygen saturation and blood pressure. Primary adverse effects inclu-ding severe arrhythmia, venous thrombosis or hemorrhage and severe hypotension were observed. The efficacy indicators including rate of death and severe disability, exercise and cognition development index were as-sessed. Results Severe arrhythmia, hypotension and renal failure were not found in both groups. Follow-up was conducted until postnatal 18 months and was not available in 6 babies (3 in SHC group and 3 in control group respectively). Death and severe disability occurred in 4 of 18 infants (22.2%)in SHC group and in 9 of 17 infants(52.9% ) in the control group respectively (P<0.05). Conclusion SHC for 72 h with mild systemic hypothermia in neonates with HIE is safe and effective. The therapy could reduce the risk of disabili-ty and handicap significantly. Key words: Hypothermia,induced; Neonate; Hypoxic-ischemic encephalopathy