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

NCT ID: NCT01757782

Last Updated: 2022-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-09-30

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.

Conditions

Meconium Aspiration Syndrome; Persistent Pulmonary Hypertension of Newborn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Oral Sildenafil

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo (distilled water)

Intervention Type: DRUG

Distill water oral

Interventions

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

Intervention Type: DRUG

Placebo (distilled water)

Distill water oral

Intervention Type: DRUG

Other Intervention Names

Viagra; Integra; Water

Eligibility 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

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 12 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sir Takhtasinhji General Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jayendra R. Gohil, MD, PROF.

Professor in Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jayendra R Gohil, MD

Role: PRINCIPAL_INVESTIGATOR

Professor Pediatrics, Govt Medical College, Bhavnagar, Gujarat, India

Locations

NICU, Pediatrics department, SirTakhtasinhjiGH

Bhavnagar, Gujarat, India

Countries

India

References

Vargas-Origel A, Gomez-Rodriguez G, Aldana-Valenzuela C, Vela-Huerta MM, Alarcon-Santos SB, Amador-Licona N. The use of sildenafil in persistent pulmonary hypertension of the newborn. Am J Perinatol. 2010 Mar;27(3):225-30. doi: 10.1055/s-0029-1239496. Epub 2009 Oct 28.

Reference Type: BACKGROUND

PMID: 19866403 (View on PubMed)

Other Identifiers

Sildenafil

Identifier Type: -

Identifier Source: org_study_id