NCT06098833View on ClinicalTrials.gov

Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 1, 2024

Primary Completion Date

October 31, 2027

Study Completion Date

June 30, 2028

Conditions
Neonatal Encephalopathy
Interventions
DRUG

Sildenafil

Sildenafil per os twice a day for seven consecutive days (from day 2 of life to day 9 of life) if brain injury on day 2 of life (dose 1=2mg/kg/dose, dose 2=2.5mg/kg/dose, and doses 3-14=3mg/kg/dose)

DRUG

Ora-Blend

Ora-Blend per os twice a day for seven consecutive days (from day 2 of life to day 9 of life) if brain injury on day 2 of life (dose 1=2mg/kg/dose, dose 2=2.5mg/kg/dose, and doses 3-14=3mg/kg/dose)

Trial Locations (2)

H3C 0T3

RECRUITING

Montreal Children's Hospital, Montreal

H3T 1C5

RECRUITING

Centre Hospitalier Universitaire Sainte-Justine, Montreal

All Listed Sponsors
lead

Pia Wintermark

OTHER