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Cooling blankets tested to save newborn brains after oxygen loss

NCT ID NCT01192776

Disease control Sponsor: NICHD Neonatal Research Network Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested four different cooling treatments for newborns who suffered brain injury from lack of oxygen at birth. The treatments varied in how low the body temperature was lowered (33.5°C or 32.0°C) and how long cooling lasted (72 or 120 hours). The goal was to see which approach best reduced death or disability by 18-22 months of age. The trial enrolled 364 infants but was terminated early, so findings are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Whole-body cooling (a procedure using a cooling blanket to lower body temperature)
What this could lead to
If successful, this could identify the best cooling method (temperature and duration) to reduce death or long-term disability in newborns with brain injury from oxygen deprivation.
What could go wrong
The trial was terminated early, so results may be incomplete. Cooling treatments can have side effects like heart rhythm problems or blood clotting issues, and the optimal approach remains uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

364 people

The number who actually took part.

Start date

Sep 2010

Finished

Mar 2016

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 6 hours

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Eligibility will be determined in a stepped process: 1. All infants with a gestational age ≥ 36 weeks will be screened for study entry if they are admitted to the NICU with a diagnosis of fetal acidosis, perinatal asphyxia, neonatal depression or encephalopathy. 2. Infants will be eligible if: * They have a pH ≤ 7.0 or a base deficit ≥ 16m mEq/ L on umbilical cord or any postnatal sample within 1 hour of age. * If, during this interval, they have a pH between 7.01 and 7.15, a base deficit is between 10 and 15.9 mEq/L, or a blood gas is not available, AND they have an acute perinatal event AND either a 10-minute Apgar score ≤ 5 or assisted ventilation initiated at birth and continued for at least 10 minutes. 3. Once these criteria are met, eligible infants will have a standardized neurological examination performed by a certified physician examiner. Infants will be candidates for the study when encephalopathy or seizures are present. For this study, encephalopathy is defined as the presence of 1 or more signs in 3 of the following 6 categories: * Level of consciousness: lethargy, stupor or coma; * Spontaneous activity: decreased, absent; * Posture: distal flexion, decerebrate; * tone: hypotonia, flaccid or hypertonia, rigid; * Primitive reflexes: a) suck, weak, absent; b) Moro, incomplete, flaccid; * Autonomic nervous system: a) pupils: constricted, unequal, skew deviation or non reactive to light; b) heart rate: bradycardia, variable heart rate or c) respiration: periodic breathing, apnea. Eligible infants from multiple births will be enrolled in the same arm of the study. Exclusion Criteria: * Inability to randomize by 6 hours of age * Major congenital abnormality * Major chromosomal abnormality (including Trisomy 21), * Severe growth restriction (≤ 1800gm birth weight), * Infant is moribund and will not receive any further aggressive treatment, * Refusal of consent by parent * Refusal of consent by attending neonatologist * Infants with a core temperature \< 33.5°C for \> 1 hour at the time of screening by the research team would not be eligible for the study.

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia Hypothermia Hypoxia, Brain perinatal asphyxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Encephalopathy, hypoxic-ischemic Hypoxia, brain Hypoxia-ischemia, brain Hypoxic-ischemic encephalopathy Infant, newborn Ischemic-hypoxic encephalopathy

Contacts and locations

Locations

  • Brown University, Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905, United States

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

    Cleveland, Ohio, 44106, United States

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108, United States

  • Cincinnati Children's Medical Center

    Cincinnati, Ohio, 45267, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Emory University

    Atlanta, Georgia, 30303, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • RTI International

    Durham, North Carolina, 27705, United States

  • Research Institute at Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • Univeristy of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of California - Los Angeles

    Los Angeles, California, 90025, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of New Mexico

    Albuquerque, New Mexico, 87131, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75235, United States

  • Wayne State University

    Detroit, Michigan, 48201, United States

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