Sildenafil Plus Hypothermia to Treat Neonatal Encephalopathy

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Plasma concentrations of Sildenafil within the first 5 days following treatment initiation. — From 3 hours after initiation of sildenafil and 48 hours after end of maintenance continuous infusion
  Pharmacokinetics features of IV sildenafil in neonates with HIE and treated by controlled hypothermia.

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France