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

Phase 4

Completed

• Conditions: Meconium Aspiration Syndrome; Persistent Pulmonary Hypertension of Newborn
• Interventions: Drug: Oral Sildenafil; Drug: Placebo (distilled water)

• Registration Number: NCT01757782
• Lead Sponsor: Sir Takhtasinhji General Hospital

Brief 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.

Detailed 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 Timeline

• Study Start: 2011-12
• Primary Completion: 2012-08
• Study Completion: 2012-09
• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2012-12-21
• Study First Posted: 2012-12-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-15
• Last Update Posted: 2022-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Sildenafil	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.
Distilled water	Placebo (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.

Primary Outcome Measures

Name	Time	Method
Improvement in oxygen saturation (SpO2)	26 hours, 50 hours	Preductal and postductal oxygen saturation (SpO2) 2 hours after dose of oral sildenafil (24 hours and 48 hours)

Secondary Outcome Measures

Name	Time	Method
Oxygenation index	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 \[fraction of inspired oxygen- FiO2\] \[Arterial partial pressure of oxygen- PaO2\]

Trial Locations

Locations (1)

NICU, Pediatrics department, SirTakhtasinhjiGH; 🇮🇳 Bhavnagar, Gujarat, India