Late Hypothermia for Hypoxic-Ischemic Encephalopathy

Summary

This study is a randomized, placebo-controlled, clinical trial to evaluate whether induced whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in infants ≥ 36 weeks gestational age with hypoxic-ischemic encephalopathy will reduce the incidence of death or disability at 18-22 months of age. The study will enroll 168 infants with signs of hypoxic-ischemic encephalopathy at 16 NICHD Neonatal Research Network sites, and randomly assign them to either receive hypothermia or participate in a non-cooled control group.

Conditions

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

Interventions

PROCEDURE

Hypothermia

Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours

PROCEDURE

Normothermic Control

Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours

Sponsors & Collaborators

• National Center for Research Resources (NCRR)

  collaborator NIH

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Abbot R. Laptook, MD · Brown University, Women & Infants Hospital of Rhode Island

• Michele C. Walsh, MD MS · Case Western Reserve University, Rainbow Babies and Children's Hospital

• Ronald N. Goldberg, MD · Duke University

• Barbara J. Stoll, MD · Emory University

• Brenda B. Poindexter, MD MS · Indiana University

• Abhik Das, PhD · RTI International

• Krisa P. Van Meurs, MD · Stanford University

• Ivan D. Frantz III, MD · Tufts Medical Center

• Kurt Schibler, MD · Children's Hospital Medical Center, Cincinnati

• Waldemar A. Carlo, MD · University of Alabama at Birmingham

• Edward F. Bell, MD · University of Iowa

• Kristi L. Watterberg, MD · University of New Mexico

• Myra Wyckoff, MD · University of Texas, Southwestern Medical Center at Dallas

• Kathleen A. Kennedy, MD MPH · The University of Texas Health Science Center, Houston

• Roger G. Faix, MD · University of Utah

• Seetha Shankaran, MD · Wayne State University

• Richard A. Ehrenkranz, MD · Yale University

• William Truog, MD · Children's Mercy Hospital Kansas City

• Barbara Schmidt, MD, MSc · University of Pennsylvania

• Carl D'Angio, MD · University of Rochester

• Uday Devaskar, MD · University of California, Los Angeles

• Pablo Sanchez, M.D · Ohio State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Hours

Max Age

24 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-04-30

Primary Completion

2016-06-30

Completion

2016-06-30

Countries

• United States

Study Locations