Cool Prime Comparative Effectiveness Study for Mild HIE

Recruiting Observational Study
Mild Hypoxic Ischemic Encephalopathy of Newborn
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
36 Weeks and older
Sex
Any
Study type
Observational
Participants needed
460 (estimated)
Sponsor
University of Texas Southwestern Medical Center · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
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 mode…
Contacts

Lina Chalak, MD

214-648-3903

lina.chalak@utsouthwestern.edu

CONTACT

Pollieanna Sepulveda, MSN, RN

214-648-3698

pollieanna.sepulveda@utsouthwestern.edu

CONTACT