At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Systemic Hypothermia Initiated After 6 Hours of Age in Infants ≥36 Weeks Gestation With Hypoxic-Ischemic Encephalopathy: A Bayesian Evaluation. A Protocol for the NICHD Neonatal Research Network
In Brief
A clinical study evaluating Hypothermia and Normothermic Control for Infant, Newborn and 5 related conditions. Completed, enrolled 168 participants across 22 sites.
Detailed Summary
This study is a randomized, placebo-controlled, clinical trial to evaluate whether induced whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in infants ≥ 36 weeks gestational age with hypoxic-ischemic encephalopathy will reduce the incidence of death or disability at 18-22 months of age. The study will enroll 168 infants with signs of hypoxic-ischemic encephalopathy at 16 NICHD Neonatal Research Network sites, and randomly assign them to either receive hypothermia or participate in a non-cooled control group.
Study Details
Timeline
Interventions
Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours