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

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 degrees 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.