Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Hypoxic ischemic encephalopathy, or HIE, is a type of brain damage. It occurs when a baby’s brain doesn’t get enough oxygen before or shortly after birth. Worldwide, 1 million infants die each year from HIE. Babies with HIE can have serious health problems such as infections, heart disease, or trauma to the brain.

Hypothermia therapy, or whole-body cooling, can increase a baby’s chance of survival and prevent health problems later in life. Whole-body cooling involves lowering the baby’s body temperature within the first six hours after birth. Whole-body cooling is an effective treatment for babies who have moderate to severe HIE. But questions remain about whether whole-body cooling works well to treat babies with mild HIE.

In this study, the research team is looking to see if whole-body cooling is a safe and effective way to treat babies with mild HIE.

Who can this research help?

Results may help doctors and parents when considering ways to treat babies with mild HIE.

What is the research team doing?

The research team is enrolling families of 430 babies who were born with mild HIE receiving treatment from academic medical centers in Texas and Georgia. Babies receive whole-body cooling or usual care based on each center’s standard practice. Babies receiving whole-body cooling have their body temperature lowered by a few degrees for 72 hours. Doctors then rewarm the babies over several hours. In usual care, doctors keep babies’ bodies at normal body temperature for 72 hours.

The research team is following families for two years to learn about babies’ brain and language development. The team is also looking at adverse events, such as a baby’s blood not clotting properly, to measure the safety of whole-body cooling. Parents are also answering questions about how well they bonded with their child.

Infant brain injury groups and families affected by HIE are helping to plan and conduct this study.

Research methods at a glance

Design ElementDescription
DesignObservational: cohort study
Population430 infants born at term, defined as ≥35 weeks gestational age
Interventions/
Comparators
  • Therapeutic hypothermia
  • Normothermia
Outcomes

Primary: results of Hammersmith Neonatal Neurological Examination, Bayley Scales of Infant and Toddler Development IV score

Secondary: serious adverse events at discharge, infant behavioral-social functioning, Mother-to-Infant Bonding Scale score, Parenting Stress Index

Timeframe  Timeframe Length of follow-up for collecting data on primary outcomes. View Glossary 2-year follow-up for primary outcomes

Project Information

Lina Chalak, MD
UT Southwestern Medical Center
$7,000,000
COOL PRIME: Cooling Mild HIE Parental Selection of Outcomes

Key Dates

July 2022
April 2029
2022

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: January 12, 2024