Oral Sildenafil in Persistent Pulmonary Hypertension Secondary to Meconium Aspiration Syndrome in Newborns

PHASE4CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

August 31, 2012

Study Completion Date

September 30, 2012

Conditions
Meconium Aspiration SyndromePersistent Pulmonary Hypertension of Newborn
Interventions
DRUG

Oral Sildenafil

Patients were randomized into two groups. Placebo was prepared with distilled water. In group A, newborns received oral Sildenafil solution through feeding tube which was prepared by crushing a 50 mg tablet of sildenafil in distilled water to make a concentration of 5 mg/ml. In group B, newborns received placebo. The protocol for dosing was (1) first dose of 1 mg/kg/dose within 30 minutes admission or within 12 hours of delivery (whichever earlier), (2) Dosing every six hours for a maximum of 8 doses, (3) Dose was doubled if the oxygenation index (OI) or SpO2 did not improve (If OI continued to be \<10% of previous value and SpO2 was not increasing \>5 of previous value) and blood pressure remained stable

DRUG

Placebo (distilled water)

Distill water oral

Trial Locations (1)

364002

NICU, Pediatrics department, SirTakhtasinhjiGH, Bhavnagar

All Listed Sponsors
lead

Sir Takhtasinhji General Hospital

OTHER_GOV

NCT01757782 - Oral Sildenafil in Persistent Pulmonary Hypertension Secondary to Meconium Aspiration Syndrome in Newborns | Biotech Hunter | Biotech Hunter