NCT02826941

Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 35 Weeks
• Healthy volunteers: Not accepted

Summary

This study was a multicenter, randomized, controlled pilot trial of moderate systemic hypothermia (33°C) vs normothermia (37°C) for 48 hours in infants with neonatal encephalopathy instituted within 6 hours of birth or hypoxic-ischemic event.

Detailed description

The trial tested the ability to initiate systemic hypothermia in outlying hospitals and participating tertiary care centers, and determined the incidence of adverse neurologic outcomes of death and developmental scores at 12 months by Bayley II or Vineland tests between normothermic and hypothermic groups. This trial identified potential safety outcomes, compared the adverse effects of hypothermia among hypoxic-ischemic encephalopathy (HIE) infants in the normothermic and hypothermic treatment groups, and obtained rates of adverse outcomes.

Conditions

• Neonatal Asphyxial Encephalopathy
• Hypoxic Ischemic Encephalopathy

Interventions

Type	Name	Description
OTHER	hypothermia	Systemic hypothermia by Cincinnati Sub-Zero Blanketrol II®, servo-controlled to 33.0 degrees C rectal temperature, started within 6hours of hypoxic ischemic birth, and continued for 48hours
OTHER	normothermia	Rectal temperatures in neonates receiving normothermia were maintained at 37.0+or -0.5 degrees C, using overhead warmer or Cincinnati Sub-Zero Blanketrol II®, servo-controlled to rectal temperature of 37.0 degrees C.

Timeline

• Start date: 1999-06-01
• Primary completion: 2004-06-01
• Completion: 2004-06-01
• First posted: 2016-07-11
• Last updated: 2016-07-11