Late Hypothermia for Hypoxic-Ischemic Encephalopathy (NCT00614744) | Clinical Trial Compass
CompletedNot Applicable
Late Hypothermia for Hypoxic-Ischemic Encephalopathy
United States168 participantsStarted 2008-04
Plain-language 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 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.
Who can participate
Age range
6 Hours – 24 Hours
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Death or Moderate or Severe Disability
Timeframe: Birth to 18-22 months corrected gestational age