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Terminated Not applicable Interventional Results available

Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE)

ClinicalTrials.gov ID: NCT01192776

Public ClinicalTrials.gov record NCT01192776. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 8:45 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Optimizing Cooling Strategies at < 6 Hours of Age for Neonatal Hypoxic-Ischemic Encephalopathy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01192776
Recruitment status
Terminated
Study type
Interventional
Phase
Not applicable
Enrollment
364 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Up to 6 Hours
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 2010 (Type not available)
Primary completion
Mar 2016 (Actual)
Completion
Mar 2016 (Actual)
Last update posted
Jun 24, 2026

2010 – 2016

United States locations

U.S. sites
19
U.S. states
14
U.S. cities
18
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233 —
University of California - Los Angeles Los Angeles California 90025 —
Stanford University Palo Alto California 94304 —
Emory University Atlanta Georgia 30303 —
Indiana University Indianapolis Indiana 46202 —
University of Iowa Iowa City Iowa 52242 —
Wayne State University Detroit Michigan 48201 —
Children's Mercy Hospital Kansas City Missouri 64108 —
University of New Mexico Albuquerque New Mexico 87131 —
University of Rochester Rochester New York 14642 —
RTI International Durham North Carolina 27705 —
Duke University Durham North Carolina 27710 —
Cincinnati Children's Medical Center Cincinnati Ohio 45267 —
Case Western Reserve University, Rainbow Babies and Children's Hospital Cleveland Ohio 44106 —
Research Institute at Nationwide Children's Hospital Columbus Ohio 43205 —
Univeristy of Pennsylvania Philadelphia Pennsylvania 19104 —
Brown University, Women & Infants Hospital of Rhode Island Providence Rhode Island 02905 —
University of Texas Southwestern Medical Center at Dallas Dallas Texas 75235 —
University of Texas Health Science Center at Houston Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01192776, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 24, 2026 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01192776 live on ClinicalTrials.gov.

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