Sildenofil in Persistent Pulmonary Hypertension in Newborns

PHASE3UnknownINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

November 30, 2014

Study Completion Date

June 30, 2015

Conditions
Persistent Fetal Circulation Syndrome
Interventions
DRUG

Sildenafil

50 mg tablet will be thoroughly crushed into powder form and diluted in 10 ml ora base suspension syrup agent and a dilution will be performed to prepare 5 mg/ml. All doses required for 48 hours will be available; solutions will be stored at 2-8 degrees C where solution should be stable for at least a month.

DRUG

diluent

The placebo will have an equal volume of diluent - Orabase syrup of the same colour and viscosity as the active comparator. Infants in this group will receive normal saline as placebo every 6 hours

Trial Locations (1)

00974

RECRUITING

Women's hospital, NICU, Doha

Sponsors
All Listed Sponsors
lead

Hamad Medical Corporation

INDUSTRY

NCT01558466 - Sildenofil in Persistent Pulmonary Hypertension in Newborns | Biotech Hunter | Biotech Hunter