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IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: May 10, 2011
Last updated: May 24, 2012
Last verified: May 2012
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
Intervention Model: Single Group Assignment
Masking: None (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 ]
  • Need for inhaled nitric oxide or Extracorporeal membrane oxygenation [ Time Frame: Day 1-14 ]

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

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


Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01360671

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01360671     History of Changes
Other Study ID Numbers: A1481294
Study First Received: May 10, 2011
Last Updated: May 24, 2012

Keywords provided by Pfizer:
persistent pulmonary hypertension of the newborn

Additional relevant MeSH terms:
Hypertension, Pulmonary
Persistent Fetal Circulation Syndrome
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Infant, Newborn, Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents processed this record on September 19, 2017