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TERMINATED
NCT01192776
NA

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

Sponsor: NICHD Neonatal Research Network

View on ClinicalTrials.gov

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.

Official title: Optimizing Cooling Strategies at < 6 Hours of Age for Neonatal Hypoxic-Ischemic Encephalopathy

Key Details

Gender

All

Age Range

Any - 6 Hours

Study Type

INTERVENTIONAL

Enrollment

364

Start Date

2010-09

Completion Date

2016-03

Last Updated

2026-06-24

Healthy Volunteers

No

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.

Locations (19)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of California - Los Angeles

Los Angeles, California, United States

Stanford University

Palo Alto, California, United States

Emory University

Atlanta, Georgia, United States

Indiana University

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

Wayne State University

Detroit, Michigan, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

University of New Mexico

Albuquerque, New Mexico, United States

University of Rochester

Rochester, New York, United States

RTI International

Durham, North Carolina, United States

Duke University

Durham, North Carolina, United States

Cincinnati Children's Medical Center

Cincinnati, Ohio, United States

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Research Institute at Nationwide Children's Hospital

Columbus, Ohio, United States

Univeristy of Pennsylvania

Philadelphia, Pennsylvania, United States

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States