NCT01793129

Preemie Hypothermia for Neonatal Encephalopathy

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: NICHD Neonatal Research Network · Network
• Sex: All
• Age: 33 Weeks – 35 Weeks
• Healthy volunteers: Not accepted

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.

Detailed description

Most clinical studies of neonatal encephalopathy (NE) and potential interventions have focused on infants ≥36 weeks GA. Although many interventions have been suggested and assessed for prevention or palliation of NE, the only one currently supported by rigorous clinical evidence to improve outcome in human newborns has been hypothermia implemented at \<6 hours of postnatal age and maintained for 72 hrs. Data about diagnosis, frequency, severity, and outcome of NE in infants 33-35 weeks GA are sparse. This trial will assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at \<6 hrs postnatal age with moderate to severe neonatal encephalopathy. Infants 33 0/7 to 35 6/7 weeks GA (best obstetrical estimate) and greater than or equal to 1500 grams birth weight (selected to minimize potential difficulties placing esophageal probe) who meet clinical, biochemical and neurologic criteria for moderate to severe NE will be randomized to either whole body hypothermia or participate in a non-cooled control group. The primary outcome will be death or moderate to severe disability at 18-22 months corrected age. The presence or absence of disability will be determined by the standard NRN interdisciplinary follow-up exam. Secondary Study includes determining an association between MRI detectable injury and neurodevelopment at 18-22 months.

Conditions

• Infant, Newborn
• Hypoxia, Brain
• Hypoxia-Ischemia, Brain
• Encephalopathy, Hypoxic-Ischemic
• Hypoxic-Ischemic Encephalopathy
• Ischemic-Hypoxic Encephalopathy

Interventions

Type	Name	Description
DEVICE	Hypothermia	Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 72 hours
PROCEDURE	Normothermic Control	Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours

Timeline

• Start date: 2015-05-01
• Primary completion: 2022-12-09
• Completion: 2022-12-09
• First posted: 2013-02-15
• Last updated: 2024-11-04
• Results posted: 2024-04-22

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated device study