NCT04621279

Cool Prime Comparative Effectiveness Study for Mild HIE

COOLPRIME: Comparative Effectiveness for Cooling Prospectively Infants With Mild Encephalopathy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 460 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 36 Weeks
• Healthy volunteers: Not accepted

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.

Detailed description

This study leverages practice variation within and across 15 participating sites to compare the effectiveness of TH versus normothermia for mild HIE on neurodevelopmental outcomes at 2 years of age.After standardizing all aspects of clinical care for mild HIE (except for TH vs. normothermia)we will enroll 460 infants with mild HIE into the longitudinal, observational comparative effectiveness study.The central aim of the comparative longitudinal cohort of mild HIE is (1) to compare the effectiveness of hypothermia to normothermia on neurodevelopmental outcomes at 2 years, (2) determine the adverse effects of TH on the infant and his/her family; and (3) determine the heterogeneity of treatment effects (moderating effect) across mild HIE subgroups as determined by physiological biomarkers obtained during the 6 hours window to initiate hypothermia. The decision to apply TH or normothermia will be entirely determined by practice parameters at each site.

Conditions

• Mild Hypoxic Ischemic Encephalopathy of Newborn

Interventions

Type	Name	Description
PROCEDURE	Normothermia	Usual care for first 72 hours for neonates with mild encephalopathy maintaining core temperature (36.5°C ± 1 C).
PROCEDURE	Whole 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.

Timeline

• Start date: 2023-07-19
• Primary completion: 2026-10-31
• Completion: 2029-01-01
• First posted: 2020-11-09
• Last updated: 2025-12-08

Locations

1 site across 1 country: United States