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NCT00005772 · ClinicalTrials.gov registry record · Phase 3
Whole-Body Cooling for Birth Asphyxia in Term Infants
A Phase 3 study, sponsored by NICHD Neonatal Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 208
- Enrollment target
NCT00005772 is a Phase 3 study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 208 participants.
The verdict
NCT00005772, a Phase 3 study, has completed, sponsored by NICHD Neonatal Research Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 208 participants
- Enrollment target
Study Summary
This large multicenter trial tested whether cerebral cooling initiated within 6 hours of birth and continued for 72 hours would reduce the risk of death and moderate to severe neurodevelopmental injury at 18-22 months corrected age. Infants at least 36 weeks gestation with an abnormal blood gas within 1 hour of birth, or a history of an acute perinatal event and a 10-min Apgar score \<5, or continued need for ventilation were screened. Following a neurological exam, those with moderate to severe encephalopathy were randomized to a 72-hour period of total body cooling (cooling blanket, followed by slow re-warming). The study was conducted in two phases: Phase I (20 infants) were examined for the safety of an esophageal temperature of 34-35 C; Phase II (main trial, 200 infants) were evaluated for the safety and efficacy of an esophageal temperature of 33-34 C. Cardio-respiratory, electroencephalograms (EEGs), renal, metabolic, and hematologic status, and esophageal and abdominal skin temperature were monitored during the 72 hours of intervention. Surviving children were given neurodevelopmental examinations at 18-22 months corrected age and again at school age (6-7 years of age).
Interventions
- DEVICE Control
- DEVICE Induced hypothermia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 1999-10 |
| Est. Completion | 2010-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00005772
The ClinicalTrials.gov registry entry for NCT00005772 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 208 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Neonatal Research Network, which has 61 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT00005772 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00005772 about?
NCT00005772 is a clinical study titled "Whole-Body Cooling for Birth Asphyxia in Term Infants". This large multicenter trial tested whether cerebral cooling initiated within 6 hours of birth and continued for 72 hours would reduce the risk of death and moderate to severe neurodevelopmental injury at 18-22 months corrected age. Infants at least 36 weeks gestation with an abnormal blood gas with...
What is the current status of trial NCT00005772?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 208 participants. The study started on 1999-10. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00005772?
The interventions under investigation include: Control (DEVICE), Induced hypothermia (DEVICE).
Who is sponsoring clinical trial NCT00005772?
This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.
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