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Sildenafil Plus Hypothermia to Treat Neonatal Encephalopathy
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
The main objective of this study is to assess pharmacokinetics features of IV sildenafil in neonates with hypoxic-ischemic encephalopathy and treated by controlled hypothermia. This phase 2 study will prepare a large phase 3 randomized controlled trial to demonstrate the superiority of a combinatory therapy associating IV sildenafil and controlled hypothermia compared to Placebo and controlled hypothermia, on survival without brain lesions on MRI at discharge, in neonates born after 36 weeks of gestation.
Official title: Effect of Sildenafil in Association to Hypothermia on Survival Without Brain Lesions In Term Neonates With Hypoxic-ischemic Encephalopathy (SHINE): Pharmacokinetic Study - Step 1
Key Details
Gender
All
Age Range
Any - 12 Hours
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-10
Completion Date
2029-05
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
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
Locations (1)
Unité de Recherche Clinique, Entrepôts de données et Pharmacologie GHU Paris Centre
Paris, France