Therapeutic Hypothermia Using Gel Packs for Term Neonates with Hypoxic Ischaemic Encephalopathy in Resource-limited Settings: a Randomized Controlled Trial

Objective: To evaluate the efficacy of therapeutic hypothermia (TH) using gel packs in reducing mortality and morbidity in term neonates with HIE and study the associated problems with TH. Methods: Hypoxic ischaemic encephalopathy babies were randomized into TH and control group. Babies in TH group were cooled for first 72?h of birth using cloth covered cooling gel packs to maintain target rectal temperature of 33-34°C. Infants were followed up to 6 months and were assessed using Baroda Developmental Screening Test. Results: There were no significant differences in baseline parameters. TH group showed significant reduction in the combined rate of death or developmental delay at 6 months of age by 21% (8.1% in the TH group vs. 29% in the control, RR 0.28, 95% CI: 0.11-0.70; p?=?0.003). Conclusions: TH using gel packs reduces the risk of death or developmental delay at 6 months of age in infants with HIE. Trial registration number: CTRI/2011/06/001780.