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NCT00614744 · ClinicalTrials.gov registry record · NA
Late Hypothermia for Hypoxic-Ischemic Encephalopathy
A NA study, sponsored by NICHD Neonatal Research Network.
- Completed
- Registry status
- NA
- Development phase
- 168
- Enrollment target
NCT00614744: Completed NA study, sponsored by NICHD Neonatal Research Network.
NCT00614744 is a NA study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 168 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00614744, a NA study, has completed, sponsored by NICHD Neonatal Research Network.
- COMPLETED
- Registry status
- NA
- Development phase
- 168 participants
- Enrollment target
Study 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.
Primary Outcome
Severe disability was defined by any of the following: a Bayley III cognitive score \< 70 or Gross Motor Functional (GMF) Level of 3-5 blindness or profound hearing loss requiring amplification but still unable to follow commands/communicate. Moderate disability was defined as a Bayley III cognitive score between 70-84 and either a GMF level of 2 or a seizure disorder or a hearing deficit.
Interventions
- PROCEDURE Normothermic Control
- PROCEDURE Hypothermia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2008-04 |
| Est. Completion | 2016-06 |
| Phase | NA |
What the finished NCT00614744 record still lists
NCT00614744 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Normothermic Control is the first listed.
NCT00614744 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00614744 about?
NCT00614744 is a clinical study titled "Late Hypothermia for Hypoxic-Ischemic Encephalopathy". 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...
What is the current status of trial NCT00614744?
This trial is currently completed. It is a NA study. The enrollment target is 168 participants. The study started on 2008-04. Estimated completion is 2016-06.
What interventions are being tested in trial NCT00614744?
The interventions under investigation include: Normothermic Control (PROCEDURE), Hypothermia (PROCEDURE).
Who is sponsoring clinical trial NCT00614744?
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 NCT00614744's enrollment target sits among peer trials
168 619th of 2000 higher than 1,379 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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