FindMyKOL
Clinical trialNCT01793129CompletedInterventional

Preemie Hypothermia for Neonatal Encephalopathy

SponsorNICHD Neonatal Research NetworkEnrollment168Encephalopathy, Hypoxic-IschemicHypoxia, BrainHypoxia-Ischemia, BrainHypoxic-Ischemic EncephalopathyInfant, NewbornIschemic-Hypoxic Encephalopathy
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

18 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Alabama at Birmingham

    Birmingham, Alabama, United States

  • Stanford University

    Palo Alto, California, United States

  • Emory University

    Atlanta, Georgia, United States

  • Indiana University

    Indianapolis, Indiana, United States

  • University of Iowa

    Iowa City, Iowa, United States

  • Wayne State University

    Detroit, Michigan, United States

  • University of New Mexico

    Albuquerque, New Mexico, United States

  • University of Rochester

    Rochester, New York, United States

  • Duke University

    Durham, North Carolina, United States

  • Rti International

    Durham, North Carolina, United States

  • Cincinnati Children'S Medical Center

    Cincinnati, Ohio, United States

  • Case Western Reserve University, Rainbow Babies and Children'S Hospital

    Cleveland, Ohio, United States

  • Research Institute at Nationwide Children'S Hospital

    Columbus, Ohio, United States

  • Univeristy of Pennsylvania

    Philadelphia, Pennsylvania, United States

  • Brown University, Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, United States

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, United States

  • University of Texas Health Science Center at Houston

    Houston, Texas, United States

  • University of Utah

    Salt Lake City, Utah, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 May 2015
Primary completion
9 Dec 2022
Completion
9 Dec 2022
Last update posted
4 Nov 2024
Registered enrollment
168
Registry id
NCT01793129

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.