Trial Search Results

Late Hypothermia for Hypoxic-Ischemic Encephalopathy

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

NICHD Neonatal Research Network

Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Stanford Investigator(s):

Intervention(s):

  • Procedure: Hypothermia
  • Procedure: Normothermic Control

Phase:

Phase 2/Phase 3

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

Ages Eligible for Study

N/A - 24 Hours

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Bethany Ball
6507358342
Not Recruiting