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Mild HIE and therapeutic hypothermia: gaps in knowledge with under-powered trials

2024/09/17 by Lina F. Chalak, Donna M. Ferriero, Alistair J. Gunn +5
Medicine · #Neonatal and fetal brain pathology #Cardiac Arrest and Resuscitation #Neonatal Respiratory Health Research

paper · pdf · doi:10.1038/s41390-024-03537-1

Abstract

The publication of a recent pilot randomized clinical trial (RCT) that investigated whole-body hypothermia (48 or 72 h) as a therapeutic intervention 1 for infants with mild hypoxic-ischemic encephalopathy (HIE), has prompted experts in trial design in therapeutic hypothermia (TH) to consider opportunities to better understand this trial and the implications for future study designs. This study included 101 patients across six sites (UK and Italy) and aimed to examine whether term infants with mild encephalopathy undergoing TH for 72 h, starting within 6 h, had higher (better) thalamic 1H-magnetic resonance spectroscopy (MRS) N-acetyl aspartate (NAA) concentrations (examined on day 4–14 as a proxy for clinical outcomes) than those who were randomized to standard care at targeted normothermia. The second question in the study compared outcomes related to the length of therapeutic hypothermia (48 or 72 h) for infants randomized after 6 h of age.

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