Whole-Body Cooling for Birth Asphyxia in Term Infants

Summary

This large multicenter trial tested whether cerebral cooling initiated within 6 hours of birth and continued for 72 hours would reduce the risk of death and moderate to severe neurodevelopmental injury at 18-22 months corrected age. Infants at least 36 weeks gestation with an abnormal blood gas within 1 hour of birth, or a history of an acute perinatal event and a 10-min Apgar score \<5, or continued need for ventilation were screened. Following a neurological exam, those with moderate to severe encephalopathy were randomized to a 72-hour period of total body cooling (cooling blanket, followed by slow re-warming). The study was conducted in two phases: Phase I (20 infants) were examined for the safety of an esophageal temperature of 34-35 C; Phase II (main trial, 200 infants) were evaluated for the safety and efficacy of an esophageal temperature of 33-34 C. Cardio-respiratory, electroencephalograms (EEGs), renal, metabolic, and hematologic status, and esophageal and abdominal skin temperature were monitored during the 72 hours of intervention. Surviving children were given neurodevelopmental examinations at 18-22 months corrected age and again at school age (6-7 years of age).

Conditions

• Infant, Newborn
• Hypoxia-Ischemia, Brain

Interventions

DEVICE

Induced hypothermia

Whole-body cooling using the Blanketrol II or III Units in the Automatic Control Mode with a YSI 400 series temperature probe placed in the distal esophagus over a 96-hour period

DEVICE

Control

Control group: standard care

Sponsors & Collaborators

• National Center for Research Resources (NCRR)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Seetha Shankaran, MD · Wayne State University

• Abbot R. Laptook, MD · Brown University, Womens and Infants Hospital of Rhode Island

• Michele C. Walsh, MD MS · Case Western Reserve University

• 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

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

• Neil N. Finer, MD · University of California, San Diego

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

• Shahnaz Duara, MD · University of Miami

• Dale L. Phelps, MD · University of Rochester

• Pablo J. Sanchez, MD · University of Texas, Southwestern Medical Center at Dallas

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

• T. Michael O'Shea, MD · Wake Forest University

• Richard A. Ehrenkranz, MD · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

6 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1999-10-31

Primary Completion

2003-05-31

Completion

2010-07-31

Countries

• United States

Study Locations