Overview

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

Status:
Completed

Trial end date:
2012-09-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Sir Takhtasinhji General Hospital

Treatments:

Sildenafil Citrate

Criteria

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