RecruitingNCT04621279

Cool Prime Comparative Effectiveness Study for Mild HIE

COOLPRIME: Comparative Effectiveness for Cooling Prospectively Infants With Mild Encephalopathy

Sponsor

University of Texas Southwestern Medical Center

Enrollment

460 participants

Start Date

Jul 19, 2023

Study Type

OBSERVATIONAL

Conditions

Mild Hypoxic Ischemic Encephalopathy of Newborn

Summary

To determine effectiveness of therapy to improve neurodevelopmental outcomes in infants with mild HIE. To determine the adverse effects of Therapeutic Hypothermia (TH) in mild HIE on the neonate and his/her family. Determine heterogeneity of the treatment effect across key subgroups obtained in the first 6 hours after birth prior to the decision to initiate therapy.

Eligibility

Min Age: 36 Weeks

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Normothermia and a procedure called Whole body therapeutic hypothermia for people with mild hypoxic ischemic encephalopathy of newborn. The study is currently recruiting participants at 1 location. People eligible for this study include aged 36 Weeks and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURENormothermia

Usual care for first 72 hours for neonates with mild encephalopathy maintaining core temperature (36.5°C ± 1 C).

PROCEDUREWhole body therapeutic hypothermia

Whole-body therapeutic hypothermia (33.5°C ± 0.5°C) for 72 hours began by 6 hours of age for neonates with mild encephalopathy per site standard of care practice.

Locations(1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

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NCT04621279