Cool Prime Comparative Effectiveness Study for Mild HIE

RecruitingOBSERVATIONAL
Enrollment

460

Participants

Timeline

Start Date

July 19, 2023

Primary Completion Date

October 1, 2027

Study Completion Date

January 1, 2029

Conditions
Mild Hypoxic Ischemic Encephalopathy of Newborn
Interventions
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.

Trial Locations (1)

75208

RECRUITING

University of Texas Southwestern Medical Center, Dallas

All Listed Sponsors
collaborator

Nationwide Children's Hospital

OTHER

collaborator

University of California, San Francisco

OTHER

collaborator

Children's National Research Institute

OTHER

collaborator

Children's Hospital Los Angeles

OTHER

collaborator

St. Louis University

OTHER

collaborator

Stanford University

OTHER

collaborator

University of Utah

OTHER

collaborator

University of Pittsburgh Medical Center

OTHER

collaborator

Emory University

OTHER

collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

collaborator

University College Cork

OTHER

collaborator

The Children's Hospital of San Antonio

OTHER

collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

collaborator

Harvard University

OTHER

collaborator

Washington University School of Medicine

OTHER

collaborator

Sharp HealthCare

OTHER

lead

University of Texas Southwestern Medical Center

OTHER