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NCT01360671 Clinical Trial

IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn

Persistent Pulmonary Hypertension of the Newborn Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01360671
Other study ID # A1481294
Secondary ID PPHN MIRROR STUD
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date March 2012
Est. completion date April 2013

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender All
Age group N/A to 72 Hours
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy - incidence of treatment failure Day 1-14
Primary Need for inhaled nitric oxide or Extracorporeal membrane oxygenation Day 1-14
Secondary Changes in oxygenation index 6 & 12 hours
Secondary Changes in differential saturation 6 & 12 hours
Secondary Duration of mechanical ventilation Days 1-14
Secondary Time from initiation of sildenafil to inhaled nitric oxide or extracorporeal membrane oxygenation Days 1-14
See also
  Status Clinical Trial Phase
Completed NCT04328636 - Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn Phase 1/Phase 2
Recruiting NCT02380040 - Plethismographic Perfusion Index in Neonates N/A
Terminated NCT02261883 - Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn Phase 2
Completed NCT04841070 - NEURodevelopmental Outcome After Persistent Pulmonary Hypertension Of the Newborn N/A
Recruiting NCT05741229 - The Effect Of Nebulizied Nitroglycerin As An Adjuvant Therapy For Persistent Pulmonary Hypertension Of Newborns N/A
Recruiting NCT00710177 - PTGS1 Genetic Variation and Increased Risk for Persistent Pulmonary Hypertension of the Newborn
Completed NCT01670136 - Pharmacokinetics of Sildenafil in Premature Infants Phase 1
Completed NCT02940327 - Markers of Inflammation and Lung Recovery in ECMO Patients for PPHN
Terminated NCT01389856 - Persistent Pulmonary Hypertension of the Newborn Phase 3
Terminated NCT01069861 - Study To Investigate Safety And Efficacy Of Sildenafil In The Newborns With Persistent Pulmonary Hypertension (PPHN) Phase 2
Active, not recruiting NCT02951130 - Milrinone in Congenital Diaphragmatic Hernia Phase 2
Enrolling by invitation NCT04938167 - Preductal Oxygen Saturation Target in Term and Late Preterm Neonates With Hypoxemic Respiratory Failure or Pulmonary Hypertension N/A
Not yet recruiting NCT04379180 - Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN

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