Late Hypothermia for Hypoxic-Ischemic Encephalopathy

Not Recruiting

Trial ID: NCT00614744

Age - 6 Hours-24 Hours Condition - Pediatric Neurology, Neonatal and Developmental Medicine Gender - All Accepting Healthy Volunteers - No

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

Stanford Investigator(s)

David K. Stevenson, M.D.

Eligibility


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

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Intervention(s):

procedure: Normothermic Control

procedure: hypothermia

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Bethany Ball
6507358342

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