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Study identifier: NCT04621279 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Cool Prime Comparative Effectiveness Study for Mild HIE

Condition: Mild Hypoxic Ischemic Encephalopathy of Newborn  ·  Sponsor: University of Texas Southwestern Medical Center

PhaseN/A
Planned participants460
Who can joinAll sexes, 36 Weeks to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Lina Chalak, MD  ·  214-648-3903  ·  lina.chalak@utsouthwestern.edu

Pollieanna Sepulveda, MSN, RN  ·  214-648-3698  ·  pollieanna.sepulveda@utsouthwestern.edu

Always discuss trial participation with your own doctor first.

Locations (1)

University of Texas Southwestern Medical CenterDallas, Texas, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT04621279