Late Hypothermia for Hypoxic-Ischemic Encephalopathy
Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain
About this trial
This is an interventional treatment trial for Infant, Newborn focused on measuring NICHD Neonatal Research Network, Hypoxic-ischemic encephalopathy (HIE), Hypothermia, Neonatal depression, Perinatal asphyxia
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
Sites / Locations
- University of Alabama at Birmingham
- University of California - Los Angeles
- Stanford University
- Yale University
- Emory University
- Indiana University
- University of Iowa
- Tufts Medical Center
- Wayne State University
- Children's Mercy Hospital
- University of New Mexico
- University of Rochester
- RTI International
- Duke University
- Cincinnati Children's Medical Center
- Case Western Reserve University, Rainbow Babies and Children's Hospital
- Research Institute at Nationwide Children's Hospital
- Univeristy of Pennsylvania
- Brown University, Women & Infants Hospital of Rhode Island
- University of Texas Southwestern Medical Center at Dallas
- University of Texas Health Science Center at Houston
- University of Utah
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Whole-body Hypothermia
Normothermia
Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours