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

Last updated on August 9, 2018

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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Study To Investigate Safety And Efficacy Of Sildenafil In The Newborns With Persistent Pulmonary Hypertension (PPHN)
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)
Sildenafil is efficacious in newborns with persistent pulmonary hypertension and its use will reduce the need for inhaled nitric oxide.
Letter 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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • PPHN
  • Persistent Pulmonary Hypertension of the Newborn
  • Hypoxic Respiratory Failure
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.
Experimental: one
Intervention: Drug: sildanefil
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
November 2011
November 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 72 Hours   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01069861
A1481276
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 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 thte study website. To get updates and notications about this trail, sign up using the form below.

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