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IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn

Last updated on December 15, 2017

FOR MORE INFORMATION
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.
Show details

- 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Withdrawn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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IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn
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)
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Persistent Pulmonary Hypertension of the Newborn
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
Experimental: Sildenafil
iv sildenafil
Intervention: Drug: Sildenafil
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
April 2013
April 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 72 Hours   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Canada
 
NCT01360671
A1481294
PPHN MIRROR STUDY
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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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1-800-718-1021

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[email protected]



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