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IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn

Last updated on November 17, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Persistent Pulmonary Hypertension of the Newborn
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.
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- Babies respiratory failure associated with idiopathic PPHN, meconium aspiration, sepsis or
pneumonia

- Oxygenation index >15 and

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

- Congenital anomaly

- Large left to right intracardiac or ductal shunt

- Already on inhaled nitric oxide

NCT01360671
Pfizer
Withdrawn
IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn

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Descriptive Information
Brief Title  ICMJE IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn
Official Title  ICMJE 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)
Brief SummaryTo 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Persistent Pulmonary Hypertension of the Newborn
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Sildenafil
iv sildenafil
Intervention: Drug: Sildenafil
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 24, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2011)
30
Estimated Study Completion Date  ICMJE April 2013
Estimated Primary Completion DateApril 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 Not Provided
Removed Location CountriesCanada
 
Administrative Information
NCT Number  ICMJE NCT01360671
Other Study ID Numbers  ICMJE A1481294
PPHN MIRROR STUDY
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 DateMay 2012

ICMJE     Data element required by the

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

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