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Completed Not applicable Interventional Results available

Preemie Hypothermia for Neonatal Encephalopathy

ClinicalTrials.gov ID: NCT01793129

Public ClinicalTrials.gov record NCT01793129. 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 22, 2026, 2:26 AM EDT

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

Official title

A Randomized Trial of Targeted Temperature Management With Whole Body Hypothermia For Moderate And Severe Hypoxic-Ischemic Encephalopathy In Premature Infants 33-35 Weeks Gestational Age.

Brief summary

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

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.

Study identification

NCT ID
NCT01793129
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Enrollment
168 participants

Conditions and interventions

Eligibility (public fields only)

Age range
33 Weeks to 35 Weeks
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
May 2015 (Type not available)
Primary completion
Dec 9, 2022 (Actual)
Completion
Dec 9, 2022 (Actual)
Last update posted
Nov 4, 2024

2015 – 2022

United States locations

U.S. sites
18
U.S. states
14
U.S. cities
17
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233 —
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 —
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 —
University of Utah Salt Lake City Utah 84108 —

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 NCT01793129, 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 Nov 4, 2024 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01793129 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →