IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn

Phase 2

Withdrawn

• Conditions: Persistent Pulmonary Hypertension of the Newborn
• Interventions: Drug: Sildenafil

• Registration Number: NCT01360671
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-10
• Study First Submitted QC: 2011-05-24
• Study First Posted: 2011-05-26
• Study Start: 2012-03
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sildenafil	Sildenafil	iv sildenafil

Primary Outcome Measures

Name	Time	Method
Efficacy - incidence of treatment failure	Day 1-14
Need for inhaled nitric oxide or Extracorporeal membrane oxygenation	Day 1-14

Secondary Outcome Measures

Name	Time	Method
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