Cool Prime Comparative Effectiveness Study for Mild HIE

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.

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.

Sponsors & Collaborators

• University of California, San Francisco

  collaborator OTHER

• Children's National Research Institute

  collaborator OTHER

• Children's Hospital Los Angeles

  collaborator OTHER

• St. Louis University

  collaborator OTHER

• Stanford University

  collaborator OTHER

• University of Utah

  collaborator OTHER

• University of Pittsburgh Medical Center

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• University College Cork

  collaborator OTHER

• The Children's Hospital of San Antonio

  collaborator OTHER

• Harvard University

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Sharp HealthCare

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• University of Florida Health

  collaborator OTHER

• Emory University

  collaborator OTHER

• Nationwide Children's Hospital

  collaborator OTHER

• Children's Hospital of Orange County

  collaborator OTHER

• University of Texas Southwestern Medical Center

  lead OTHER

Principal Investigators

• Lina Chalak, MD · University of Texas Southwestern Medical Center

Eligibility

Min Age

36 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-19

Primary Completion

2026-10-31

Completion

2029-01-01

Countries

• United States

Study Locations