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
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.
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.
| Measure | Time Frame |
| Improvement in oxygen saturation (SpO2) | 26 hours, 50 hours |
| Measure | Time Frame |
| Oxygenation index | 26 hours, 50 hours |
- Meconium Aspiration Syndrome
- Persistent Pulmonary Hypertension of Newborn
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
– 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
| Last Name | Role | Affiliation |
| Jayendra R Gohil, MD | Principal Investigator | Professor Pediatrics, Govt Medical College, Bhavnagar, Gujarat, India |
| Facility: | NICU, Pediatrics department, SirTakhtasinhjiGH |
Type: Principal Investigator
Investigator Affiliation: Sir Takhtasinhji General Hospital
Investigator Full Name: Jayendra R. Gohil, MD, PROF.
Investigator Title: Professor in Pediatrics
- MAS
- PPHN
- Sildenafil
- Newborn
- Pulmonary Hypertension
- Hypertension, Pulmonary
- Meconium Aspiration Syndrome
- Persistent Fetal Circulation Syndrome
- Hypertension
- Syndrome
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.
