Preemie Hypothermia for Neonatal Encephalopathy

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

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

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

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

• Seetha Shankaran, MD · Wayne State University

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

• C. Michael Cotten, MD · Duke University

• David P Carlton, MD · Emory University

• Greg Sokol, MD, MS · Indiana University

• Abhik Das, PhD · RTI International

• Krisa P Van Meurs, MD · Stanford University

• Brenda Poindexter, MD · Children's Hospital Medical Center, Cincinnati

• Wally 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 Dalla

• Jon E Tyson, MD, MPH · The University of Texas Health Science Center, Houston

• Eric Eichenwald, MD · University of Pennsylvania

• Carl T D'Angio, MD · University of Rochester

• Pablo Sanchez, MD · Research Institute at Nationwide Children's Hospital

• Bradley Yoder, MD · University of Utah

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

33 Weeks

Max Age

35 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2022-12-09

Completion

2022-12-09

FDA Device

Yes

Countries

• United States

Study Locations