Late Hypothermia for Hypoxic-Ischemic Encephalopathy

Trial ID or NCT#

NCT00614744

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 6 Hours to 24 Hours
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  2. * 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:
  1. * 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
View All Criteria
Show Less

Investigator(s)

David K. Stevenson, M.D.

Contact us to find out if this trial is right for you.

Contact

Bethany Ball
6507358342

View on ClinicalTrials.gov