Reply to: Benefits and risks of therapeutic hypothermia for hypoxic-ischemic encephalopathy in late preterm infants

Abstract

In their recently online-published Review Article, El-Dib included multiple critiques of our Randomized Controlled Trial (RCT) of Whole Body Hypothermia in Preterm Infants 33-35 Wks Gestation. We agree that more data from larger studies may help to further assess safety and efficacy of therapeutic hypothermia (TH) for infants 35 wks GA or less, provided that such studies are rigorously designed, implemented and reported. Given the results of our trial, the efficacy and safety of hypothermia in this population has not been established. Responses to many of the issues they raise about our trial are included. For now, the results of our RCT remain the best available data regarding therapeutic hypothermia in this population. IMPACT: This letter responds to issues raised by previously published review article (El-Dib et al.) in this journal. Most of the issues raised that were not included in primary manuscript of our published RCT are addressed. Despite the limitations of our randomized, controlled trial, it remains the best available data regarding therapeutic hypothermia in 33-35 weeks gestational age infants with hypoxic-ischemic encephalopathy and does not support effectiveness.