96
Participants
Start Date
December 31, 2011
Primary Completion Date
August 31, 2012
Study Completion Date
September 30, 2012
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
Placebo (distilled water)
Distill water oral
NICU, Pediatrics department, SirTakhtasinhjiGH, Bhavnagar
Sir Takhtasinhji General Hospital
OTHER_GOV