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

NCT01757782 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2022-05-20

No results posted yet for this study

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.

Conditions

  • Meconium Aspiration Syndrome
  • Persistent Pulmonary Hypertension of Newborn

Interventions

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

DRUG

Placebo (distilled water)

Distill water oral

Sponsors & Collaborators

  • Sir Takhtasinhji General Hospital

    lead OTHER_GOV

Principal Investigators

  • Jayendra R Gohil, MD · Professor Pediatrics, Govt Medical College, Bhavnagar, Gujarat, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
12 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-08-31
Completion
2012-09-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01757782 on ClinicalTrials.gov