Late Hypothermia for Hypoxic-Ischemic Encephalopathy
Trial ID or NCT#
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.
Evaluation of Systemic Hypothermia Initiated After 6 Hours of Age in Infants ≥36 Weeks Gestation With Hypoxic-Ischemic Encephalopathy: A Bayesian Evaluation. A Protocol for the NICHD Neonatal Research Network
- - 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).
- - 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
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