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Study To Investigate Safety And Efficacy Of Sildenafil In The Newborns With Persistent Pulmonary Hypertension (PPHN)

Last updated on November 11, 2019

FOR MORE INFORMATION
Study Location
Great Ormond Street Hospital, Paediatric Intensive Care
London, , WC1N 3JH United Kingdom
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
PPHN, Persistent Pulmonary Hypertension of the Newborn, Hypoxic Respiratory Failure
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-72
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 72 hours of age; and > or = to 34 weeks gestational age.

- Persistent Pulmonary Hypertension of the Newborn or Hypoxic respiratory failure
associated with:

1. Idiopathic PPHN or

2. Meconium aspiration syndrome or

3. Sepsis or

4. Pneumonia

- Oxygenation Index (OI) >15 and

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients already receiving inhaled nitric oxide (iNO) on referral.

- Prior or immediate need for full Cardio Pulmonary Resuscitation or Extracorporeal
Membrane Oxygenation (ECMO).

- Life threatening or lethal congenital anomaly.

- Large left to right intracardiac or ductal shunting (diagnosed from echocardiogram on
admission to GOSH).

- Clinically significant active seizures as per clinical judgment.

- Bleeding diathesis as per clinical judgment

NCT01069861
Pfizer
Terminated
Study To Investigate Safety And Efficacy Of Sildenafil In The Newborns With Persistent Pulmonary Hypertension (PPHN)

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Descriptive Information
Brief Title  ICMJE Study To Investigate Safety And Efficacy Of Sildenafil In The Newborns With Persistent Pulmonary Hypertension (PPHN)
Official Title  ICMJE A Single Arm Single Centre Study To Investigate Safety And Efficacy Of Sildenafil In Near Term And Term Newborns With Persistent Pulmonary Hypertension Of The Newborn (PPHN)
Brief SummarySildenafil is efficacious in newborns with persistent pulmonary hypertension and its use will reduce the need for inhaled nitric oxide.
Detailed DescriptionLetter to investigator dated 18 June 2012 that study was to be terminated. Study terminated due to evolved and widespread use of standard of care, relevance of study questioned. No safety reasons or issues.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • PPHN
  • Persistent Pulmonary Hypertension of the Newborn
  • Hypoxic Respiratory Failure
Intervention  ICMJE Drug: sildanefil
Intravenous sildenafil citrate will be administered as a loading dose of 0.1 mg/kg given over 30 minutes. This will be followed by a maintenance treatment consisting of an intravenous infusion of 0.03 mg/kg/hr. The duration of the infusion will be determined by the need of the individual patient, but will be reviewed at Day 7 if still ongoing, and will not continue past Day 14.
Study Arms  ICMJE Experimental: one
Intervention: Drug: sildanefil
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 22, 2012)
4
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2010)
40
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion DateNovember 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 72 hours of age; and > or = to 34 weeks gestational age.
  • Persistent Pulmonary Hypertension of the Newborn or Hypoxic respiratory failure associated with:

    1. Idiopathic PPHN or
    2. Meconium aspiration syndrome or
    3. Sepsis or
    4. Pneumonia
  • Oxygenation Index (OI) >15 and <60 calculated

Exclusion Criteria:

  • Patients already receiving inhaled nitric oxide (iNO) on referral.
  • Prior or immediate need for full Cardio Pulmonary Resuscitation or Extracorporeal Membrane Oxygenation (ECMO).
  • Life threatening or lethal congenital anomaly.
  • Large left to right intracardiac or ductal shunting (diagnosed from echocardiogram on admission to GOSH).
  • Clinically significant active seizures as per clinical judgment.
  • Bleeding diathesis as per clinical judgment
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE up to 72 Hours   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01069861
Other Study ID Numbers  ICMJE A1481276
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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