24
Participants
Start Date
July 31, 2025
Primary Completion Date
February 28, 2026
Study Completion Date
January 31, 2028
Sildenafil Citrate (IV)
Controlled hypothermia initiated before 6h after birth (servo-controlled 33.5°C during 72h followed by a 12-h rewarming period up to 36.5°C), open-label IV Sildenafil Citrate (Revatio®, 10 mg/12.5 mL, Pfizer) 0.4 mg/kg delivered over 3 hours, followed by a maintenance infusion at 1.6 mg/kg/day for 72h
Unité de Recherche Clinique, Entrepôts de données et Pharmacologie GHU Paris Centre, Paris
Assistance Publique - Hôpitaux de Paris
OTHER