Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE)

Stopped early · Not applicable

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

In brief

The Optimizing Cooling trial will compare four whole-body cooling treatments for infants born at 36 weeks gestational age or later with hypoxic-ischemic encephalopathy: (1) cooling for 72 hours to 33.5°C; (2) cooling for 120 hours to 33.5°C; (3) cooling for 72 hours to 32.0°C; and (4) cooling for 120 hours to 32.0°C. The objective of this study is to evaluate whether whole-body cooling initiated at less than 6 hours of age and continued for 120 hours and/or a depth at 32.0°C in will reduce death and disability at 18-22 months corrected age.

Key facts

Study ID: NCT01192776
Run by: NICHD Neonatal Research Network
People needed: 364
Starts: 2010-09-01
Expected to finish: 2016-03-01
Last updated by the study team: 2026-06-24

Who can join

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

You may qualify if…

Eligibility will be determined in a stepped process:
All infants with a gestational age ≥ 36 weeks will be screened for study entry if they are admitted to the NICU with a diagnosis of fetal acidosis, perinatal asphyxia, neonatal depression or encephalopathy.
Infants will be eligible if:
They have a pH ≤ 7.0 or a base deficit ≥ 16m mEq/ L on umbilical cord or any postnatal sample within 1 hour of age.
If, during this interval, they have a pH between 7.01 and 7.15, a base deficit is between 10 and 15.9 mEq/L, or a blood gas is not available, AND they have an acute perinatal event AND either a 10-minute Apgar score ≤ 5 or assisted ventilation initiated at birth and continued for at least 10 minutes.
Once these criteria are met, eligible infants will have a standardized neurological examination performed by a certified physician examiner. Infants will be candidates for the study when encephalopathy or seizures are present. For this study, encephalopathy is defined as the presence of 1 or more signs in 3 of the following 6 categories:
Level of consciousness: lethargy, stupor or coma;
Spontaneous activity: decreased, absent;
Posture: distal flexion, decerebrate;
tone: hypotonia, flaccid or hypertonia, rigid;
Primitive reflexes: a) suck, weak, absent; b) Moro, incomplete, flaccid;
Autonomic nervous system: a) pupils: constricted, unequal, skew deviation or non reactive to light; b) heart rate: bradycardia, variable heart rate or c) respiration: periodic breathing, apnea.
Eligible infants from multiple births will be enrolled in the same arm of the study.

You may not qualify if…

Inability to randomize by 6 hours of age
Major congenital abnormality
Major chromosomal abnormality (including Trisomy 21),
Severe growth restriction (≤ 1800gm birth weight),
Infant is moribund and will not receive any further aggressive treatment,
Refusal of consent by parent
Refusal of consent by attending neonatologist
Infants with a core temperature < 33.5°C for > 1 hour at the time of screening by the research team would not be eligible for the study.

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
Emory University — Atlanta, Georgia, United States
Indiana University — Indianapolis, Indiana, United States
University of Iowa — Iowa City, Iowa, 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

Full record on ClinicalTrials.gov

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