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NCT01192776 · ClinicalTrials.gov registry record · NA
Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE)
A NA study, sponsored by NICHD Neonatal Research Network.
- Terminated
- Registry status
- NA
- Development phase
- 364
- Enrollment target
NCT01192776: Clinical Trial NA study, sponsored by NICHD Neonatal Research Network.
NCT01192776 is a NA study that was terminated before completion, run by NICHD Neonatal Research Network. The registered enrollment target is 364 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01192776, a NA study, was terminated before completion, sponsored by NICHD Neonatal Research Network.
- TERMINATED
- Registry status
- NA
- Development phase
- 364 participants
- Enrollment target
Study Summary
The Optimizing Cooling trial will compare four whole-body cooling treatments for infants born at 36 weeks gestational age or later with hypoxic-ischemic encephalopathy: (1) cooling for 72 hours to 33.5°C; (2) cooling for 120 hours to 33.5°C; (3) cooling for 72 hours to 32.0°C; and (4) cooling for 120 hours to 32.0°C. The objective of this study is to evaluate whether whole-body cooling initiated at less than 6 hours of age and continued for 120 hours and/or a depth at 32.0°C in will reduce death and disability at 18-22 months corrected age.
Primary Outcome
Death includes any mortality prior to follow up at 18-22 months. Severe disability was defined by any of the following: a Bayley III cognitive score \<70, a GMFCS level of 3-5, blindness or profound hearing loss (inability to understand commands despite amplification). Moderate disability was defined as a Bayley cognitive score of 70-84 and either a GMFCS level of 2, seizure disorder, or a hearing deficit requiring amplification to understand commands.
Interventions
- PROCEDURE Whole-body Cooling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 364 participants |
| Start Date | 2010-09 |
| Est. Completion | 2016-03 |
| Phase | NA |
Why NCT01192776 stopped before completion
NCT01192776 is an interventional study that assigns participants to a tested intervention. The registered 364 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 (74% lower).
The record links to 0 conditions, and to 1 intervention - of which Whole-body Cooling is the first listed.
NCT01192776 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01192776 about?
NCT01192776 is a clinical study titled "Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE)". The Optimizing Cooling trial will compare four whole-body cooling treatments for infants born at 36 weeks gestational age or later with hypoxic-ischemic encephalopathy: (1) cooling for 72 hours to 33.5°C; (2) cooling for 120 hours to 33.5°C; (3) cooling for 72 hours to 32.0°C; and (4) cooling for 12...
What is the current status of trial NCT01192776?
This trial is currently terminated. It is a NA study. The enrollment target is 364 participants. The study started on 2010-09. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01192776?
The interventions under investigation include: Whole-body Cooling (PROCEDURE).
Who is sponsoring clinical trial NCT01192776?
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 NCT01192776's enrollment target sits among peer trials
364 284th of 2000 higher than 1,717 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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