Clinical Trials Logo
  1. Home
  2. Meconium Aspiration Syndrome
  3. NCT01757782

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

Meconium Aspiration Syndrome Clinical Trial

Official title:
Oral Sildenafil in Persistent Pulmonary Hypertension of Neonates Secondary to Meconium Aspiration Syndrome: A Randomized Placebo Controlled Trial

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01757782
Study type Interventional
Source Sir Takhtasinhji General Hospital
Contact
Status Completed
Phase Phase 4
Start date December 2011
Completion date September 2012
View Details
See also
  Status Clinical Trial Phase
Completed NCT02041546 - Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome Phase 4
Completed NCT04076189 - Time of Positive Pressure Ventilation in Non-vigorous Infants Born Through Meconium-stained Amniotic Fluid N/A
Not yet recruiting NCT02571231 - High Flow Ventilation With Volume Guarantee N/A
Completed NCT01758822 - Role of Endotracheal Suction on the Occurrence of Meconium Aspiration Syndrome in Non-vigorous Meconium Stained Babies N/A
Completed NCT01328483 - Effect Of Intrapartum Oropharyngeal (IP-OP) Suction on Meconium Aspiration Syndrome N/A
Recruiting NCT06090981 - Early Bolus Surfactant Replacement Therapy Versus Standard Care in Term Neonates With Meconium Aspiration Syndrome N/A
Withdrawn NCT03996317 - Maternal Hyperoxygenation for Intrapartum Fetal Heart Rate Tracing Abnormalities N/A
Withdrawn NCT02708563 - Meconium Aspiration and Tracheal Suctioning—Feasibility Study N/A
Completed NCT01310621 - Comparison Of Surfactant Lung Lavage With Standard Care In The Treatment Of Meconium Aspiration Syndrome N/A
Recruiting NCT03346343 - Pulmonary Function Using Non-invasive Forced Oscillometry N/A
Completed NCT01274845 - Use of Heliox in the Management of Neonates With Meconium Aspiration Syndrome N/A
Recruiting NCT00312507 - Surfactant Lavage vs. Bolus Surfactant in Neonates With Meconium Aspiration Phase 3