A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn



Status:Active, not recruiting
Conditions:High Blood Pressure (Hypertension), High Blood Pressure (Hypertension), Pulmonary
Therapuetic Areas:Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:3/31/2019
Start Date:August 5, 2013
End Date:December 31, 2020

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A MULTI-CENTRE, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, TWO-ARMED, PARALLEL GROUP STUDY TO EVALUATE EFFICACY AND SAFETY OF IV SILDENAFIL IN THE TREATMENT OF NEONATES WITH PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN (PPHN) OR HYPOXIC RESPIRATORY FAILURE AND AT RISK FOR PPHN, WITH A LONG TERM FOLLOW-UP INVESTIGATION OF DEVELOPMENTAL PROGRESS 12 AND 24 MONTHS AFTER COMPLETION OF STUDY TREATMENT

This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide
treatment and reduce the failure rate of available treatments for persistent pulmonary
hypertension of the newborn.


Inclusion Criteria:

- Neonates with persistent pulmonary hypertension of the newborn

- Age <=96 hours and >=34 weeks gestational age

- Oxygenation Index >15 and <60

- Concurrent treatment with inhaled nitric oxide and >=50% oxygen

Exclusion Criteria:

- Prior or immediate need for extracorporeal membrane oxygenation or cardiopulmonary
resuscitation

- Expected duration of mechanical ventilation <48 hours

- Profound hypoxemia

- Life-threatening or lethal congenital anomaly
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1 Children's Way
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940 NE 13th St
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Seattle, Washington 98105
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