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

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

Source 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.

Overall Status Completed Start Date December 2011 Completion Date September 2012 Primary Completion Date August 2012 Phase Phase 4 Study Type Interventional Primary Outcome
Measure Time Frame
Improvement in oxygen saturation (SpO2) 26 hours, 50 hours
Secondary Outcome
Measure Time Frame
Oxygenation index 26 hours, 50 hours
Enrollment 96 Condition

  • Meconium Aspiration Syndrome
  • Persistent Pulmonary Hypertension of Newborn
Intervention

Intervention Type: Drug

Description: 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 5 of previous value) and blood pressure remained stable

Arm Group Label: Oral Sildenafil

Intervention Type: Drug

Description: Distill water oral

Arm Group Label: Distilled water

Other Name: Water

Eligibility

– 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).

– (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

Maximum Age: 12 Hours

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jayendra R Gohil, MD Principal Investigator Professor Pediatrics, Govt Medical College, Bhavnagar, Gujarat, India
Location
Facility: NICU, Pediatrics department, SirTakhtasinhjiGH
Location Countries Verification Date Responsible Party

Type: Principal Investigator

Investigator Affiliation: Sir Takhtasinhji General Hospital

Investigator Full Name: Jayendra R. Gohil, MD, PROF.

Investigator Title: Professor in Pediatrics

Keywords
  • MAS
  • PPHN
  • Sildenafil
  • Newborn
  • Pulmonary Hypertension
Has Expanded Access No Condition Browse
  • Hypertension, Pulmonary
  • Meconium Aspiration Syndrome
  • Persistent Fetal Circulation Syndrome
  • Hypertension
  • Syndrome
Number Of Arms 2 Arm Group

Label: Oral Sildenafil

Type: Active Comparator

Description: 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.

Label: Distilled water

Type: Placebo Comparator

Description: 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.