A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn
NCT ID: NCT01720524
Last Updated: 2021-08-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
59 participants
INTERVENTIONAL
2013-08-05
2020-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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placebo
iv placebo of normal saline or 10% dextrose
placebo
IV placebo or 0.9% sodium chloride or 10% dextrose. Infusion rate based on weight.
sildenafil
Active study drug
iv sildenafil
loading dose of 0.1 mg/kg over 30 minutes followed by maintenance dose of 0.03 mg/kg/h. To infuse minimum 48 hours and maximum of 14 days.
Interventions
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placebo
IV placebo or 0.9% sodium chloride or 10% dextrose. Infusion rate based on weight.
iv sildenafil
loading dose of 0.1 mg/kg over 30 minutes followed by maintenance dose of 0.03 mg/kg/h. To infuse minimum 48 hours and maximum of 14 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \<=96 hours and \>=34 weeks gestational age
* Oxygenation Index \>15 and \<60
* Concurrent treatment with inhaled nitric oxide and \>=50% oxygen
Exclusion Criteria
* Expected duration of mechanical ventilation \<48 hours
* Profound hypoxemia
* Life-threatening or lethal congenital anomaly
0 Days
4 Days
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
University of California Davis Medical Center
Sacramento, California, United States
University of California Davis
Sacramento, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Children´s National Medical Center
Washington D.C., District of Columbia, United States
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States
Riley Hospital for Children at IU Health
Indianapolis, Indiana, United States
Sydney and Lois Eskenazi Hospital
Indianapolis, Indiana, United States
Children's Mercy Hospitals & Clinics
Kansas City, Missouri, United States
Duke University Medical Center (DUMC)
Durham, North Carolina, United States
Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
OU Follow-Up Program, PREMIEr Clinic, Children's Hospital
Oklahoma City, Oklahoma, United States
OU Neonatal Intensive Care Unit at Children's Hospital
Oklahoma City, Oklahoma, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Henry Zarrow Neonatal Intensive Care Unit, Children's Hospital at Saint Francis
Tulsa, Oklahoma, United States
Warren Cancer Research Foundation
Tulsa, Oklahoma, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
Seattle Children's Research Institute
Seattle, Washington, United States
Seattle Childrens Hospital
Seattle, Washington, United States
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
UZ Gent
Ghent, , Belgium
CHUL du CHU de Quebec
Québec, Quebec, Canada
Aarhus Universitetshospital, Skejby
Aarhus N, , Denmark
Neonatalklinikken Rigshospitalet, 5024
Copenhagen Ø, , Denmark
Centre Hospitalier et Regional de Lille - Hopital Jeanne de Flandre
Lille, , France
Centre Hospitalier et Régional de Lille,
Lille, , France
Hôpital de la Conception Assistance Publique-Hôpitaux de Marseille
Marseille, , France
CHU Robert Debré
Paris, , France
Hopital NECKER - Enfants Malades
Paris, , France
University Hospital of Leipzig
Leipzig, , Germany
Neonatologia Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Radboud University Nijmegen Medical Centre
Nijmegen, , Netherlands
Erasmus MC, Sophia Children's hospital
Rotterdam, , Netherlands
Haukeland University Hospital
Bergen, Haukeland, Norway
Hospital Sant Joan de Deu
Esplugues de Llobregat, Barcelona / Spain, Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Karolinska University Hospital
Stockholm, , Sweden
St. Michael's Hospital
Bristol, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Glenfield Hospital, University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
Great Ormond Street Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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References
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Pierce CM, Zhang MH, Jonsson B, Iorga D, Cheruvu N, Balagtas CC, Steinhorn RH. Efficacy and Safety of IV Sildenafil in the Treatment of Newborn Infants with, or at Risk of, Persistent Pulmonary Hypertension of the Newborn (PPHN): A Multicenter, Randomized, Placebo-Controlled Trial. J Pediatr. 2021 Oct;237:154-161.e3. doi: 10.1016/j.jpeds.2021.05.051. Epub 2021 May 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan: Redacted SAP Part A of study
Document Type: Statistical Analysis Plan: Redacted SAP Part B of Study
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2012-002619-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A1481316
Identifier Type: -
Identifier Source: org_study_id
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