Sildenafil to Repair Brain Injury Secondary to Birth Asphyxia

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 19, 2019

Primary Completion Date

December 31, 2021

Study Completion Date

December 31, 2024

Conditions
Birth Asphyxia
Interventions
DRUG

Sildenafil Citrate

Cohort 1 of 3-6 neonates: 1st dose of 2mg/kg/dose, 2nd dose of 2.5 mg/kg/dose, and subsequent doses of 2.5mg/kg/dose q12h (= 5 mg/kg/day from dose #2) Cohort 2 of 3-6 neonates: 1st dose of 2mg/kg/dose, 2nd dose of 2.5 mg/kg/dose, 3rd dose of 3mg/kg/dose, and subsequent doses of 3mg/kg/dose q12h (= 6 mg/kg/day from dose #3) dose expansion phase in up to 5-15 asphyxiated neonates

Trial Locations (1)

H4A3J1

Montreal Children's Hospital, Montreal

All Listed Sponsors
lead

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER