Late Hypothermia for Hypoxic-Ischemic Encephalopathy
Launched by NICHD NEONATAL RESEARCH NETWORK · Feb 11, 2008
Trial Information
Current as of April 25, 2025
Completed
Keywords
ClinConnect Summary
Hypoxic-ischemic encephalopathy (HIE) is a rare, but life-threatening condition characterized by acute or subacute brain injury due to asphyxia. In most cases the underlying cause and timing of injury are unknown, but many cases are diagnosed at or shortly after birth.
According to the World Health Organization, more than 722,000 children died from birth asphyxia and birth trauma worldwide in 2004. An estimated 50-75 percent of infants with severe (stage 3) HIE will die, with 55 percent of these deaths occurring in the first month.
The incidence of long-term complications depends on the s...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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).
- Exclusion Criteria:
- • 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
Trial Officials
Abbot R. Laptook, MD
Principal Investigator
Brown University, Women & Infants Hospital of Rhode Island
Michele C. Walsh, MD MS
Principal Investigator
Case Western Reserve University, Rainbow Babies and Children's Hospital
Ronald N. Goldberg, MD
Principal Investigator
Duke University
Barbara J. Stoll, MD
Principal Investigator
Emory University
Brenda B. Poindexter, MD MS
Principal Investigator
Indiana University
Abhik Das, PhD
Principal Investigator
RTI International
Krisa P. Van Meurs, MD
Principal Investigator
Stanford University
Ivan D. Frantz III, MD
Principal Investigator
Tufts Medical Center
Kurt Schibler, MD
Principal Investigator
Children's Hospital Medical Center, Cincinnati
Waldemar A. Carlo, MD
Principal Investigator
University of Alabama at Birmingham
Edward F. Bell, MD
Principal Investigator
University of Iowa
Kristi L. Watterberg, MD
Principal Investigator
University of New Mexico
Myra Wyckoff, MD
Principal Investigator
University of Texas, Southwestern Medical Center at Dallas
Kathleen A. Kennedy, MD MPH
Principal Investigator
The University of Texas Health Science Center, Houston
Roger G. Faix, MD
Principal Investigator
University of Utah
Seetha Shankaran, MD
Principal Investigator
Wayne State University
Richard A. Ehrenkranz, MD
Principal Investigator
Yale University
William Truog, MD
Principal Investigator
Children's Mercy Hospital Kansas City
Barbara Schmidt, MD, MSc
Principal Investigator
University of Pennsylvania
Carl D'Angio, MD
Principal Investigator
University of Rochester
Uday Devaskar, MD
Principal Investigator
University of California, Los Angeles
Pablo Sanchez, M.D
Principal Investigator
Ohio State University
About Nichd Neonatal Research Network
The NICHD Neonatal Research Network (NNR) is a premier collaborative research initiative sponsored by the National Institute of Child Health and Human Development (NICHD). It focuses on advancing the understanding and treatment of neonatal conditions through rigorous clinical trials and studies. By uniting leading medical centers and researchers, the NNR aims to improve neonatal health outcomes, enhance care practices, and contribute to evidence-based guidelines. The network emphasizes multidisciplinary approaches, innovative methodologies, and patient-centered research, making significant strides in the field of neonatal care and contributing valuable insights to pediatric medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Haven, Connecticut, United States
Birmingham, Alabama, United States
Iowa City, Iowa, United States
Kansas City, Missouri, United States
Atlanta, Georgia, United States
Rochester, New York, United States
Durham, North Carolina, United States
Detroit, Michigan, United States
Palo Alto, California, United States
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
Albuquerque, New Mexico, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Providence, Rhode Island, United States
Dallas, Texas, United States
Houston, Texas, United States
Boston, Massachusetts, United States
Los Angeles, California, United States
Columbus, Ohio, United States
Salt Lake City, Utah, United States
Philadelphia, Pennsylvania, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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