Sildenafil Plus Hypothermia to Treat Neonatal Encephalopathy

Starting soon · Phase 2

Conditions studied: Hypoxic-Ischemic Encephalopathy

In brief

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.

Key facts

Study ID

NCT06810284

Run by

Assistance Publique - Hôpitaux de Paris

People needed

24

Starts

2026-10-01

Expected to finish

2029-05-01

Last updated by the study team

2026-03-31

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1/Neonates born at or after 36 weeks' gestation, treated by therapeutic servo-controlled hypothermia for neonatal hypoxic ischemic encephalopathy.
• Therapeutic hypothermia should be decided according to French national guidelines.
• 2/ Social security coverage
• 3/ Informed consent of one of the two holders of parental authority.

You may not qualify if…

• 1/ Chromosomal aberrations and major malformations evidenced after birth
• 2/ Decision for "comfort care only" before study drug administration,
• 3/ Uncontrolled hemorrhagic syndrome,
• 4/ Severe hemodynamic failure at initiation, requiring at least two therapies (including either volume expansion, hydrocortisone or inotropes)
• 5/ Known hypersensitivity to the active substance or to any of the excipients
• 6/ Concomitant administration of nitrates or nitric oxide donors, Inhaled Nitric Oxide, other PDE5 inhibitors, inhibitors of CYP3A4
• 7/ Participation in another interventional study

Where it is running

• Unité de Recherche Clinique, Entrepôts de données et Pharmacologie GHU Paris Centre — Paris, France

Full record on ClinicalTrials.gov

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