NCT01757782|CompletedPhase 4
Oral Sildenafil in Persistent Pulmonary Hypertension Secondary to Meconium Aspiration Syndrome in Newborns
OSiNPH
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OSiNPH
Sponsor study identifier
interventional
96
1 country
1
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2012
Actual (reported)Study Completion
September 2012
Actual (reported)The purpose of this study is to to study the role of oral Sildenafil in Persistent Pulmonary Hypertension of Newborn (PPHN) secondary to Meconium Aspiration Syndrome (MAS) in newborns and to study risk factors of MAS developing into PPHN.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
August 2012
Actual (reported)September 2012
Actual (reported)December 18, 2012
Actual (reported)December 31, 2012
Actual (reported)Improvement in oxygen saturation (SpO2)
Preductal and postductal oxygen saturation (SpO2) 2 hours after dose of oral sildenafil (24 hours and 48 hours)
26 hours, 50 hours
Oxygenation index
26 hours, 50 hours
Mortality of patients enrolled in study
Upto 4 weeks
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. 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.
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.
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
NICU, Pediatrics department, SirTakhtasinhjiGH
Bhavnagar, Gujarat, 364002, India
Vargas-Origel A, Gomez-Rodriguez G, Aldana-Valenzuela C, Vela-Huerta MM, Alarcon-Santos SB, Amador-Licona N. The use of sildenafil in persistent pulmonary hypertension of the newborn. Am J Perinatol. 2010 Mar;27(3):225-30. doi: 10.1055/s-0029-1239496. Epub 2009 Oct 28.
Jayendra R Gohil, MD
Professor Pediatrics, Govt Medical College, Bhavnagar, Gujarat, India
96 participants (actual enrollment reported by the registry).
First Submitted
December 18, 2012
First Posted
December 31, 2012
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Distill water oral
Contact the study team to confirm eligibility.
Primary Completion
August 2012
Actual (reported)Study Completion
September 2012
Actual (reported)Last Updated
May 20, 2022
Record last verified: 2022-05
Available for six months on request
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