Status: Recruiting
Cool Prime Comparative Effectiveness Study for Mild HIE
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.
Participants needed: 460
Trial details
Age: 36+Biological sex: AllType: ObservationalSponsor: University of Texas Southwestern Medical CenterUpdated: Sep 25, 2026Locations: 1
Eligibility criteria
Neonates born at ≥ 36 0/7 weeks [+9]
Gestational age at birth < 36 0/7 weeks [+6]