Whole-Body Cooling for Birth Asphyxia in Term Infants
Infant, Newborn, 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: At least 36 weeks gestation Any blood gas (cord, postnatal) done within the first 60 minutes had a pH less than or equal to 7.0 Any blood gas (cord postnatal) done within the first 60 minutes had a base deficit greater than or equal to 16 mEq/L All infants must have seizures or signs of moderate to severe encephalopathy before randomization Exclusion Criteria: Inability to randomize by 6 hours of age Presence of known chromosomal anomaly or major congenital anomaly Severe intrauterine growth restriction (weight less than 1800g) All blood gases done within the first 60 minutes had a pH less than 7.15 and a base deficit less than 10 mEq/L Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist Parents refuse consent Attending neonatologist refuses consent
Sites / Locations
- University of Alabama at Birmingham
- Stanford University
- Yale University
- University of Miami
- Emory University
- Indiana University
- Harvard University
- Wayne State University
- University of New Mexico
- RTI International
- Cincinnati Children's Medical Center
- Case Western Reserve University, Rainbow Babies and Children's Hospital
- Brown University, Women & Infants Hospital of Rhode Island
- University of Tennessee
- University of Texas Southwestern Medical Center at Dallas
- University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Hypothermia
Normothermic
Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
Placebo: Normothermic control group (with esophageal temperature at or near 37.0°C) for 96 hours