A Phase 4 interventional study of Oral Sildenafil and Placebo (distilled water) in Meconium Aspiration Syndrome and Persistent Pulmonary Hypertension of Newborn, sponsored by Sir Takhtasinhji General Hospital. Completed at 1 site in India. Open to participants aged 1 Minute to 12 Hours. Per ClinicalTrials.gov, last updated 2022-05-20.
Sponsored by Sir Takhtasinhji General Hospital · Phase 4, Interventional, and Treatment
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.
Design: Randomized control trial Setting: Neonatal intensive care unit in a tertiary care hospital Patients: Patients diagnosed with MAS with PPHN according to clinical criteria. 97 patients with MAS were enrolled in the study over a period of 8 months, out of which 40 patients with PPHN were randomized into two groups.
Intervention: Group A received Sildenafil through a feeding tube (1 mg/kg/dose q6h) for 8 doses. Group B received a placebo. Outcome measures: Improvement in oxygen saturation (SpO2), oxygenation index (OI), duration of hospitalization and mechanical ventilation and mortality.
25 studies on the registry are indexed under Meconium Aspiration Syndrome; 2 are open to participants now.
This study's enrollment of 96 is above the median of 65 across 20 interventional studies indexed under Meconium Aspiration Syndrome.
Browse Meconium Aspiration Syndrome studies →Sir Takhtasinhji General Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.
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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.
Drug: Oral Sildenafil
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.
Drug: Placebo (distilled water)
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
Also known as: Viagra, Integra
Distill water oral
Also known as: Water
Improvement in oxygen saturation (SpO2)
Preductal and postductal oxygen saturation (SpO2) 2 hours after dose of oral sildenafil (24 hours and 48 hours)
Time frame: 26 hours, 50 hours
Oxygenation index
Oxygenation index of neonates kept on ventilator 2 hours after dose of oral sildenafil (24 hours and 48 hours) \[Oxygenation index (OI) = Mean airway pressure (cm H2O) × FiO2 × 100/ PaO2 \[fraction of inspired oxygen- FiO2\] \[Arterial partial pressure of oxygen- PaO2\]
Time frame: 26 hours, 50 hours
Mortality of patients enrolled in study
During time of hospital stay(upto 4 weeks).
Time frame: Upto 4 weeks
Plan to share: Yes — Available for six months on request
Supporting information: Clinical study report
Time frame: six months
Access criteria: on demand
The record gives a start of Dec 2011, a primary completion of Aug 2012 and a completion of Sep 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sildenafil
Meconium Aspiration Syndrome →
Sir Takhtasinhji General Hospital