Cool Prime Comparative Effectiveness Study for Mild HIE

Conditions

• Mild Hypoxic Ischemic Encephalopathy of Newborn

Eligibility Criteria

Sex

ALL

Age

36 Weeks - N/A

Healthy Volunteers

Not accepted

Interventions

• Normothermia — PROCEDURE
  Usual care for first 72 hours for neonates with mild encephalopathy maintaining core temperature (36.5°C ± 1 C).
• Whole body therapeutic hypothermia — PROCEDURE
  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.

Study Details

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.

Key Dates

Start date

Jul 19, 2023

Status verified

Apr 2026

Primary completion

Oct 31, 2026

Completion

Jan 1, 2029

Study Design

Enrollment

460 participants (estimated)

Arms

• Arm: Mild HIE
  Mild HIE identified in the first 6 hours of life according to the published PRIME study definition: newborn with evidence of encephalopathy (using the validated Sarnat Exam) NOT meeting prior cooling trials criteria.

Primary Outcome Measure

Effectiveness of normothermia in infants as measured by Composite Bayley IV score [ Time Frame: 22-26 months of age. ]

Central Contacts

• Lina Chalak, MD
  214-648-3903
  [email protected]
• Pollieanna Sepulveda, MSN, RN
  214-648-3698
  [email protected]

Locations (1)

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