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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: Completed Phase 3 study, sponsored by NICHD Neonatal Research Network.
NCT00005772 is a Phase 3 study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 208 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00005772 record still lists
NCT00005772 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT00005772 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00005772's enrollment target sits among peer trials
208 1345th of 2000 higher than 655 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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