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Late Hypothermia for Hypoxic-Ischemic Encephalopathy
Not Recruiting
Trial ID: NCT00614744
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)
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
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