IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn

An Open Label Single Arm, Single Centre Study to Investigate the Safety and Efficacy of IV Sildenafil in Neonates With Persistent Pulmonary Hypertension of the Newborn (PPHN)

To determine the efficacy of iv sildenafil in term and near term infants with PPHN (persistent pulmonary hypertension of the newborn), by measuring the need for inhaled nitric oxide (iNO) or extracorporeal membrane oxygenation (ECMO) compared to a historical control group not treated with sildenafil.

Study Overview

• Status: Withdrawn
• Conditions: Persistent Pulmonary Hypertension of the Newborn
• Intervention / Treatment: Drug: Sildenafil

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Babies < 72 hours old and at least 34 gestational weeks with PPHN or hypoxic respiratory failure associated with idiopathic PPHN, meconium aspiration, sepsis or pneumonia
• Oxygenation index >15 and < 60

Exclusion Criteria:

• Congenital anomaly
• Large left to right intracardiac or ductal shunt
• Already on inhaled nitric oxide

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sildenafil; iv sildenafil	Drug: Sildenafil; Loading dose of 0.1 mg/kg for 30 minutes followed by maintenance treatment of 0.03 mg/kg.h for up to 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy - incidence of treatment failure	Day 1-14
Need for inhaled nitric oxide or Extracorporeal membrane oxygenation	Day 1-14

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in oxygenation index	6 & 12 hours
Changes in differential saturation	6 & 12 hours
Duration of mechanical ventilation	Days 1-14
Time from initiation of sildenafil to inhaled nitric oxide or extracorporeal membrane oxygenation	Days 1-14

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): April 1, 2013
• Study Completion (Anticipated): April 1, 2013

Study Registration Dates

• First Submitted: May 10, 2011
• First Submitted That Met QC Criteria: May 24, 2011
• First Posted (Estimate): May 26, 2011

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: PPHN; persistent pulmonary hypertension of the newborn; sildenafil; iv
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Hypertension; Hypertension, Pulmonary; Persistent Fetal Circulation Syndrome; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: A1481294; PPHN MIRROR STUDY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No