Should mildly Brain-Injured newborns be cooled? major trial aims to find out
NCT ID NCT04621279
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether cooling therapy (lowering body temperature for 72 hours) helps babies born with mild brain injury from oxygen loss, compared to standard care without cooling. Researchers will track 460 newborns' development at age 2 and monitor side effects. The goal is to see if cooling improves long-term brain health and is safe for these infants.
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 therapeutic hypothermia (cooling therapy) or normothermia (usual care)
- What this could lead to
- If cooling works better than usual care, it could become a standard treatment to improve brain development in babies with mild HIE.
- What could go wrong
- This is a mid-stage trial with 460 babies, so results may not apply to all. Cooling has known risks like bleeding or infection, and it may not improve outcomes over simple monitoring.
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.
- Participants
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About 460 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Term infants ≥ 36 weeks' gestation with evidence of both perinatal event fetal acidosis and encephalopathy on exam.
- Ages
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36 weeks and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: Infants must meet all 3 inclusion criteria 1. Neonates born at ≥ 36 0/7 weeks 2. Mild Encephalopathy on neonatal neurologic exam within 6 hours after birth: defined as presence of at least 2 signs of mild, moderate, or severe encephalopathy with no more than 2 signs in the moderate or severe category. 3. Perinatal Acidosis based on at least one of the following (A or B): 1. pH ≤ 7.00 in any cord or first infant gas (arterial, venous, or capillary) within ≤ 60 min OR base deficit ≥ 16 in any cord or first infant gas (arterial, venous or capillary) within ≤ 60 min 2. If pH is between 7.01 and 7.15, OR base deficit is between 10 and 15.9 mmol/liter, OR blood gas is not available, an acute perinatal event is an additional criteria required (see below definition) An acute perinatal event is defined by at least one of the following: 1. Apgar score at 10 min ≤ 5 2. Continued need for resuscitation at 10 min (chest compressions, bag mask ventilation, or positive pressure ventilation) 3. Uterine rupture, placental abruption, cord accident (prolapse, rupture, knot or tight nuchal cord) 4. maternal trauma, maternal hemorrhage, or cardiorespiratory arrest 5. fetal exsanguination from either vasa previa or feto-maternal hemorrhage, shoulder dystocia 6. Any evidence suggestive of acute perinatal event. Infants are still eligible for enrollment in the COOLPRIME study if the cord or infant's first blood gas (arterial, venous, or capillary) is obtained \>60 minutes of life. Exclusion Criteria: 1. Gestational age at birth \< 36 0/7 weeks 2. Birth weight \< 1800gm 3. Head circumference \<30cm 4. Congenital or chromosomal anomaly associated with abnormal neurodevelopment or death 5. Moderate or Severe HIE of 3 or more moderate or severe abnormalities on COOLPRIME Sarnat exam within 6 hours of life 6. Any seizures within first six hours of life 7. Redirection of care is being considered
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Texas Southwestern Medical Center
RECRUITINGDallas, Texas, 75208, United States