IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01360671
Recruitment Status : Withdrawn
First Posted : May 26, 2011
Last Update Posted : May 28, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Persistent Pulmonary Hypertension of the Newborn Drug: Sildenafil Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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)
Study Start Date : March 2012
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Efficacy - incidence of treatment failure [ Time Frame: Day 1-14 ]
  2. Need for inhaled nitric oxide or Extracorporeal membrane oxygenation [ Time Frame: Day 1-14 ]

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01360671

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT01360671     History of Changes
Other Study ID Numbers: A1481294
First Posted: May 26, 2011    Key Record Dates
Last Update Posted: May 28, 2012
Last Verified: May 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