At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Trial of Targeted Temperature Management With Whole Body Hypothermia For Moderate And Severe Hypoxic-Ischemic Encephalopathy In Premature Infants 33-35 Weeks Gestational Age.
In Brief
A clinical study evaluating Hypothermia and Normothermic Control for Infant, Newborn and 5 related conditions. Completed, enrolled 168 participants across 18 sites.
Detailed Summary
This study is a randomized, controlled trial to assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at \<6 hours postnatal age with moderate to severe neonatal encephalopathy (NE). The study will enroll infants with signs of NE at 18 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 72 hours
Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours