IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01360671
First received: May 10, 2011
Last updated: May 24, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Persistent Pulmonary Hypertension of the Newborn
Drug: Sildenafil
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Efficacy - incidence of treatment failure [ Time Frame: Day 1-14 ] [ Designated as safety issue: No ]
  • Need for inhaled nitric oxide or Extracorporeal membrane oxygenation [ Time Frame: Day 1-14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in oxygenation index [ Time Frame: 6 & 12 hours ] [ Designated as safety issue: No ]
  • Changes in differential saturation [ Time Frame: 6 & 12 hours ] [ Designated as safety issue: No ]
  • Duration of mechanical ventilation [ Time Frame: Days 1-14 ] [ Designated as safety issue: No ]
  • Time from initiation of sildenafil to inhaled nitric oxide or extracorporeal membrane oxygenation [ Time Frame: Days 1-14 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360671

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01360671     History of Changes
Other Study ID Numbers: A1481294, PPHN MIRROR STUDY
Study First Received: May 10, 2011
Last Updated: May 24, 2012
Health Authority: Canada: Health Canada

Keywords provided by Pfizer:
PPHN
persistent pulmonary hypertension of the newborn
sildenafil
iv

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Persistent Fetal Circulation Syndrome
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Infant, Newborn, Diseases
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014