Questions about the HELIX trial – Authors' reply

Sudhin Thayyil,Paul Bassett,Seetha Shankaran

doi:10.1016/s2214-109x(21)00499-x

Abstract

Questions about the HELIX trial – Authors' reply

Highlights

We appreciate the clinician’s dilemma when existing practice is challenged by evidence, and have provided a combined response
Data on Apgar scores beyond 5 min and cord pH are rarely available in outborn infants from low-income and middle-income countries (LMICs)
The conclusion of our study, that LMICs should immediately suspend use of cooling in neonates, was based on the primary outcome—the trial had 81% power to conclude that hypothermia does not reduce death or disability (50% in hypothermia vs 47% in the control group; p=0·55)

Summary

Introduction

We appreciate the clinician’s dilemma when existing practice is challenged by evidence, and have provided a combined response.[1]. The conclusion of our study, that LMICs should immediately suspend use of cooling in neonates, was based on the primary outcome—the trial had 81% power to conclude that hypothermia does not reduce death or disability (50% in hypothermia vs 47% in the control group; p=0·55). Of the three predefined secondary outcomes, mortality at 18 months was higher in the hypothermic group, while severe disability and microcephaly were not significantly different.

Results

Conclusion