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

Last updated on February 23, 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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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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