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IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn

Primary Purpose

Persistent Pulmonary Hypertension of the Newborn

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sildenafil
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Pulmonary Hypertension of the Newborn focused on measuring PPHN, persistent pulmonary hypertension of the newborn, sildenafil, iv

Eligibility Criteria

undefined - 72 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Sildenafil

    Arm Description

    iv sildenafil

    Outcomes

    Primary Outcome Measures

    Efficacy - incidence of treatment failure
    Need for inhaled nitric oxide or Extracorporeal membrane oxygenation

    Secondary Outcome Measures

    Changes in oxygenation index
    Changes in differential saturation
    Duration of mechanical ventilation
    Time from initiation of sildenafil to inhaled nitric oxide or extracorporeal membrane oxygenation

    Full Information

    First Posted
    May 10, 2011
    Last Updated
    January 28, 2021
    Sponsor
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01360671
    Brief Title
    IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    March 2012 (undefined)
    Primary Completion Date
    April 2013 (Anticipated)
    Study Completion Date
    April 2013 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Persistent Pulmonary Hypertension of the Newborn
    Keywords
    PPHN, persistent pulmonary hypertension of the newborn, sildenafil, iv

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sildenafil
    Arm Type
    Experimental
    Arm Description
    iv sildenafil
    Intervention Type
    Drug
    Intervention Name(s)
    Sildenafil
    Intervention Description
    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 Measure Information:
    Title
    Efficacy - incidence of treatment failure
    Time Frame
    Day 1-14
    Title
    Need for inhaled nitric oxide or Extracorporeal membrane oxygenation
    Time Frame
    Day 1-14
    Secondary Outcome Measure Information:
    Title
    Changes in oxygenation index
    Time Frame
    6 & 12 hours
    Title
    Changes in differential saturation
    Time Frame
    6 & 12 hours
    Title
    Duration of mechanical ventilation
    Time Frame
    Days 1-14
    Title
    Time from initiation of sildenafil to inhaled nitric oxide or extracorporeal membrane oxygenation
    Time Frame
    Days 1-14

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    72 Hours
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481294&StudyName=IV%20Sildenafil%20Persistent%20Pulmonary%20Hypertension%20Of%20The%20Newborn
    Description
    To obtain contact information for a study center near you, click here.

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    IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn

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