Status:
COMPLETED
Late Hypothermia for Hypoxic-Ischemic Encephalopathy
Lead Sponsor:
NICHD Neonatal Research Network
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Infant, Newborn
Hypoxia, Brain
Eligibility:
All Genders
6-24 years
Phase:
NA
Brief Summary
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 g...
Detailed Description
Hypoxic-ischemic encephalopathy (HIE) is a rare, but life-threatening condition characterized by acute or subacute brain injury due to asphyxia. In most cases the underlying cause and timing of injury...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT00614744
Start Date
April 1 2008
End Date
June 1 2016
Last Update
March 9 2021
Active Locations (22)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of California - Los Angeles
Los Angeles, California, United States, 90025
3
Stanford University
Palo Alto, California, United States, 94304
4
Yale University
New Haven, Connecticut, United States, 06504