At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 65 enrolled

Drug / intervention

hypothermia +1 moreother

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02826941

NCT02826941Phase 2Completed

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Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy

Medical University of South Carolina·interventional·Posted Jul 11, 2016·Updated Jul 11, 2016

In Brief

A Phase 2 clinical trial evaluating hypothermia and normothermia for Neonatal Asphyxial Encephalopathy and Hypoxic Ischemic Encephalopathy. Completed, enrolled 65 participants.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsNeonatal Asphyxial Encephalopathy, Hypoxic Ischemic Encephalopathy

Countries--

CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 2CompletedFinished

19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJun 1999

Primary CompletionJun 2004

First PostedJul 2016

TodayJul 2026

First PostedJul 11, 2016

Enrollment StartJun 1, 1999

Primary CompletionJun 1, 2004

TodayJul 2, 2026

Enrollment to primary: 5 yearsPosted 10.0 years ago

Interventions

hypothermiaother

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

normothermiaother

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.