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 |
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.
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
We found this trial at
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Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Vanderbilt Children's Hospital Monroe Carell Jr. Children's Hospital at Vanderbilt is one of the nation's...
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New Brunswick, New Jersey 08901
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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University of California-Davis As we begin our second century, UC Davis is poised to become...
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2315 Stockton Blvd.
Sacramento, California 95817
Sacramento, California 95817
(916) 734-2011
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Tulsa, Oklahoma 74136
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