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

Primary Purpose

Meconium Aspiration Syndrome, Persistent Pulmonary Hypertension of Newborn

Status

Completed

Phase

Phase 4

Locations

India

Study Type

Interventional

Intervention

Oral Sildenafil

Placebo (distilled water)

About this trial

This is an interventional treatment trial for Meconium Aspiration Syndrome focused on measuring MAS, PPHN, Sildenafil, Newborn, Pulmonary Hypertension

Eligibility Criteria

1 Minute - 12 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

NICU, Pediatrics department, SirTakhtasinhjiGH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Oral Sildenafil

Distilled water

Arm 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.

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.

Outcomes

Primary Outcome Measures

Improvement in oxygen saturation (SpO2)

Preductal and postductal oxygen saturation (SpO2) 2 hours after dose of oral sildenafil (24 hours and 48 hours)

Secondary Outcome Measures

Oxygenation index

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]

Full Information

NCT ID

NCT01757782

First Posted

December 18, 2012

Last Updated

May 15, 2022

Sponsor

Sir Takhtasinhji General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01757782

Brief Title

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

Acronym

OSiNPH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sir Takhtasinhji General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meconium Aspiration Syndrome, Persistent Pulmonary Hypertension of Newborn

Keywords

MAS, PPHN, Sildenafil, Newborn, Pulmonary Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Sildenafil

Arm Type

Active Comparator

Arm Description

Arm Title

Distilled water

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Oral Sildenafil

Other Intervention Name(s)

Viagra, Integra

Intervention 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 <10% of previous value and SpO2 was not increasing >5 of previous value) and blood pressure remained stable

Intervention Type

Drug

Intervention Name(s)

Placebo (distilled water)

Other Intervention Name(s)

Water

Intervention Description

Distill water oral

Primary Outcome Measure Information:

Title

Improvement in oxygen saturation (SpO2)

Description

Preductal and postductal oxygen saturation (SpO2) 2 hours after dose of oral sildenafil (24 hours and 48 hours)

Time Frame

26 hours, 50 hours

Secondary Outcome Measure Information:

Title

Oxygenation index

Description

Time Frame

26 hours, 50 hours

Other Pre-specified Outcome Measures:

Title

Mortality of patients enrolled in study

Description

During time of hospital stay(upto 4 weeks).

Time Frame

Upto 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Minute

Maximum Age & Unit of Time

12 Hours

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jayendra R Gohil, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

NICU, Pediatrics department, SirTakhtasinhjiGH

City

Bhavnagar

State/Province

Gujarat

ZIP/Postal Code

364002

Country

India

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Available for six months on request

IPD Sharing Time Frame

six months

IPD Sharing Access Criteria

on demand

Citations:

PubMed Identifier

19866403

Citation

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.

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

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