Late Hypothermia for Hypoxic-Ischemic Encephalopathy

Completed · Not applicable

Conditions studied: Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic, Hypoxic-Ischemic Encephalopathy, Ischemic-Hypoxic Encephalopathy

In brief

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.

Key facts

Study ID

NCT00614744

Run by

NICHD Neonatal Research Network

People needed

168

Starts

2008-04-01

Expected to finish

2016-06-01

Last updated by the study team

2021-03-09

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants born at 36 0/7ths weeks gestational age or greater (by best obstetrical estimate)
• Postnatal age between 6 and 24 hours following birth
• Infants with a high probability of acute hemodynamic compromise, such as those with:
• An acute perinatal event (abruptio placenta, cord prolapse, severe FHR abnormality)
• An Apgar score ≤ 5 at 10 minutes
• Continued need for ventilation initiated at birth for at least 10 minutes
• Cord pH or first postnatal blood gas pH at ≤ 1 hour of ≤ 7.0
• Base deficit on cord gas or first postnatal blood gas at ≤ 1 hour of ≥ 16 mEq/L
• Infants matching the above criteria who also have an abnormal neurological exam showing the presence of moderate or severe encephalopathy
• Infants whose parents/legal guardians have provided consent for enrollment.
• NOTE: These inclusion criteria are identical to the NICHD Neonatal Research Network's 2005 Hypothermia study (see links below), except for the time of entry (6-24 hours vs. < 6 hours of age).

You may not qualify if…

• Any infant with a core body temperature (axilla, rectal) less than 34.0°C for greater than 1 hour
• Presence of a known anomaly or chromosomal aberration
• Birth weight < 1,800 grams
• Infant in extremis
• Infants whose parents/legal guardians or attending physician refuse consent

Where it is running

• 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
• Yale University — New Haven, Connecticut, United States
• Emory University — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• Tufts Medical Center — Boston, Massachusetts, 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
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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