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NCT01793129 · ClinicalTrials.gov registry record · NA
Preemie Hypothermia for Neonatal Encephalopathy
A NA study, sponsored by NICHD Neonatal Research Network.
- Completed
- Registry status
- NA
- Development phase
- 168
- Enrollment target
NCT01793129: Completed NA study, sponsored by NICHD Neonatal Research Network.
NCT01793129 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
NCT01793129, 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, controlled trial to assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at \<6 hours postnatal age with moderate to severe neonatal encephalopathy (NE). The study will enroll infants with signs of NE at 18 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 Function (GMF) Level of 3-5 blindness or profound hearing loss requiring amplification but still unable to following 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
- DEVICE Hypothermia
- PROCEDURE Normothermic Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2015-05 |
| Est. Completion | 2022-12-09 |
| Phase | NA |
What the finished NCT01793129 record still lists
NCT01793129 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 Hypothermia is the first listed.
NCT01793129 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01793129 about?
NCT01793129 is a clinical study titled "Preemie Hypothermia for Neonatal Encephalopathy". This study is a randomized, controlled trial to assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at \<6 hours postnatal age with moderate to severe neonatal encephalopathy (NE). The study will enroll infants with s...
What is the current status of trial NCT01793129?
This trial is currently completed. It is a NA study. The enrollment target is 168 participants. The study started on 2015-05. Estimated completion is 2022-12-09.
What interventions are being tested in trial NCT01793129?
The interventions under investigation include: Hypothermia (DEVICE), Normothermic Control (PROCEDURE).
Who is sponsoring clinical trial NCT01793129?
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 NCT01793129'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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