Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE)

Summary

The Optimizing Cooling trial will compare four whole-body cooling treatments for infants born at 36 weeks gestational age or later with hypoxic-ischemic encephalopathy: (1) cooling for 72 hours to 33.5°C; (2) cooling for 120 hours to 33.5°C; (3) cooling for 72 hours to 32.0°C; and (4) cooling for 120 hours to 32.0°C. The objective of this study is to evaluate whether whole-body cooling initiated at less than 6 hours of age and continued for 120 hours and/or a depth at 32.0°C in will reduce death and disability at 18-22 months corrected age.

Conditions

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

Interventions

PROCEDURE

Whole-body Cooling

Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 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

• Seetha Shankaran, MD · Wayne State University

• 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

• 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

• 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

• 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

• Leif Nelin, MD · Research Institute at Nationwide Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Max Age

6 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-09-30

Primary Completion

2016-03-31

Completion

2016-03-31

Countries

• United States

Study Locations