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Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy

NCT02826941 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2016-07-11

No results posted yet for this study

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.

Conditions

  • Neonatal Asphyxial Encephalopathy
  • Hypoxic Ischemic Encephalopathy

Interventions

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.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Dorothea D Jenkins, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-06-30
Primary Completion
2004-06-30
Completion
2004-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02826941 on ClinicalTrials.gov