Oral Sildenafil in Persistent Pulmonary Hypertension Secondary to Meconium Aspiration Syndrome in Newborns (OSiNPH)
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ClinicalTrials.gov Identifier: NCT01757782 |
Recruitment Status :
Completed
First Posted : December 31, 2012
Last Update Posted : May 20, 2022
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Condition or disease | Intervention/treatment | Phase |
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Meconium Aspiration Syndrome Persistent Pulmonary Hypertension of Newborn | Drug: Oral Sildenafil Drug: Placebo (distilled water) | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 96 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Oral Sildenafil in Persistent Pulmonary Hypertension of Neonates Secondary to Meconium Aspiration Syndrome: A Randomized Placebo Controlled Trial |
Study Start Date : | December 2011 |
Actual Primary Completion Date : | August 2012 |
Actual Study Completion Date : | September 2012 |

Arm | Intervention/treatment |
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Active Comparator: Oral Sildenafil
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.
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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
Other Names:
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Placebo Comparator: Distilled water
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.
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Drug: Placebo (distilled water)
Distill water oral
Other Name: Water |
- Improvement in oxygen saturation (SpO2) [ Time Frame: 26 hours, 50 hours ]Preductal and postductal oxygen saturation (SpO2) 2 hours after dose of oral sildenafil (24 hours and 48 hours)
- Oxygenation index [ Time Frame: 26 hours, 50 hours ]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]
- Mortality of patients enrolled in study [ Time Frame: Upto 4 weeks ]During time of hospital stay(upto 4 weeks).

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Ages Eligible for Study: | up to 12 Hours (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Newborns were diagnosed with MAS if any of the two of the following three criteria were present. (1) Meconium staining of liquor or staining of umbilical cord or skin or nails. (2) Respiratory distress, within one hour of birth. (3) Radiological evidence of aspiration pneumonitis (atelectasis and/or hyperinflation). Newborns with MAS diagnosed with clinical PPHN were enrolled in the study for drug trial. PPHN was determined either clinically by loud P2(second component of second heart sound), 10% or greater pre-/post ductal difference in arterial oxygenation (obtained by acid base gas analysis) or upper limb- lower limb SpO2 difference (obtained by pulse oximetry).
Exclusion Criteria:
- (a) babies with congenital heart disease (b) congenital anomalies particularly those which were incompatible to life or which was the cause for respiratory distress e.g. diaphragmatic hernia (c) Respiratory morbidities such as hyaline membrane disease, congenital pneumonia (d) Babies with PPHN secondary to MAS admitted after 12 hours of delivery (e) Non availability of consent of guardian for interventional procedures

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757782
India | |
NICU, Pediatrics department, SirTakhtasinhjiGH | |
Bhavnagar, Gujarat, India, 364002 |
Principal Investigator: | Jayendra R Gohil, MD | Professor Pediatrics, Govt Medical College, Bhavnagar, Gujarat, India |
Responsible Party: | Jayendra R. Gohil, MD, PROF., Professor in Pediatrics, Sir Takhtasinhji General Hospital |
ClinicalTrials.gov Identifier: | NCT01757782 |
Other Study ID Numbers: |
Sildenafil |
First Posted: | December 31, 2012 Key Record Dates |
Last Update Posted: | May 20, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Available for six months on request |
Supporting Materials: |
Clinical Study Report (CSR) |
Time Frame: | six months |
Access Criteria: | on demand |
MAS PPHN Sildenafil Newborn Pulmonary Hypertension |
Hypertension, Pulmonary Meconium Aspiration Syndrome Persistent Fetal Circulation Syndrome Hypertension Syndrome Disease Pathologic Processes Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Lung Injury |
Respiration Disorders Fetal Diseases Pregnancy Complications Infant, Newborn, Diseases Sildenafil Citrate Vasodilator Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Urological Agents |