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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A - 4 Days
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01720524
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Hypertension, Familial Persistent, of the Newborn
Study Website: View Trial Website
Arms & Interventions

Arms

Placebo Comparator: placebo

iv placebo of normal saline or 10% dextrose

Experimental: sildenafil

Active study drug

Interventions

Drug: - placebo

IV placebo or 0.9% sodium chloride or 10% dextrose. Infusion rate based on weight.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Arkansas Children's Hospital, Little Rock, Arkansas

Status

Address

Arkansas Children's Hospital

Little Rock, Arkansas, 72202

Sacramento, California

Status

Address

University of California Davis Medical Center

Sacramento, California, 95817

University of California Davis, Sacramento, California

Status

Address

University of California Davis

Sacramento, California, 95817

Sacramento, California

Status

Address

University of California Davis Medical Center

Sacramento, California, 95825

Children´s National Medical Center, Washington, District of Columbia

Status

Address

Children´s National Medical Center

Washington, District of Columbia, 20010

Indianapolis, Indiana

Status

Address

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202

Riley Hospital for Children at IU Health, Indianapolis, Indiana

Status

Address

Riley Hospital for Children at IU Health

Indianapolis, Indiana, 46202

Sydney and Lois Eskenazi Hospital, Indianapolis, Indiana

Status

Address

Sydney and Lois Eskenazi Hospital

Indianapolis, Indiana, 46202

Children's Mercy Hospitals & Clinics, Kansas City, Missouri

Status

Address

Children's Mercy Hospitals & Clinics

Kansas City, Missouri, 64108

Duke University Medical Center (DUMC), Durham, North Carolina

Status

Address

Duke University Medical Center (DUMC)

Durham, North Carolina, 27710

Fairview Hospital, Cleveland, Ohio

Status

Address

Fairview Hospital

Cleveland, Ohio, 44111

Cleveland Clinic, Cleveland, Ohio

Status

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Oklahoma City, Oklahoma

Status

Address

OU Follow-Up Program, PREMIEr Clinic, Children's Hospital

Oklahoma City, Oklahoma, 73104

Oklahoma City, Oklahoma

Status

Address

OU Neonatal Intensive Care Unit at Children's Hospital

Oklahoma City, Oklahoma, 73104

Oklahoma City, Oklahoma

Status

Address

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

Tulsa, Oklahoma

Status

Address

Henry Zarrow Neonatal Intensive Care Unit, Children's Hospital at Saint Francis

Tulsa, Oklahoma, 74136

Warren Cancer Research Foundation, Tulsa, Oklahoma

Status

Address

Warren Cancer Research Foundation

Tulsa, Oklahoma, 74136

Vanderbilt Children's Hospital, Nashville, Tennessee

Status

Address

Vanderbilt Children's Hospital

Nashville, Tennessee, 37232

Seattle Children's Research Institute, Seattle, Washington

Status

Address

Seattle Children's Research Institute

Seattle, Washington, 98101

Seattle Childrens Hospital, Seattle, Washington

Status

Address

Seattle Childrens Hospital

Seattle, Washington, 98105

International Sites

Universitair Ziekenhuis Antwerpen, Edegem, Belgium

Status

Address

Universitair Ziekenhuis Antwerpen

Edegem, , 2650

UZ Gent, Gent, Belgium

Status

Address

UZ Gent

Gent, , 9000

CHUL du CHU de Quebec, Quebec, Canada

Status

Address

CHUL du CHU de Quebec

Quebec, , G1V 4G2

Aarhus Universitetshospital, Skejby, Aarhus N, Denmark

Status

Address

Aarhus Universitetshospital, Skejby

Aarhus N, , 8200

Neonatalklinikken Rigshospitalet, 5024, Copenhagen Ø, Denmark

Status

Address

Neonatalklinikken Rigshospitalet, 5024

Copenhagen Ø, , 2100

Lille, France

Status

Address

Centre Hospitalier et Regional de Lille - Hopital Jeanne de Flandre

Lille, , 59037

Centre Hospitalier et Régional de Lille,, Lille, France

Status

Address

Centre Hospitalier et Régional de Lille,

Lille, , 59037

Marseille, France

Status

Address

Hôpital de la Conception Assistance Publique-Hôpitaux de Marseille

Marseille, , 13385

CHU Robert Debré, Paris, France

Status

Address

CHU Robert Debré

Paris, , 75019

Hopital NECKER - Enfants Malades, Paris, France

Status

Address

Hopital NECKER - Enfants Malades

Paris, , 75743

University Hospital of Leipzig, Leipzig, Germany

Status

Address

University Hospital of Leipzig

Leipzig, , 04103

Pavia, Italy

Status

Address

Neonatologia Fondazione IRCCS Policlinico San Matteo

Pavia, , 27100

Nijmegen, Netherlands

Status

Address

Radboud University Nijmegen Medical Centre

Nijmegen, , 6525 GA

Erasmus MC, Sophia Children's hospital, Rotterdam, Netherlands

Status

Address

Erasmus MC, Sophia Children's hospital

Rotterdam, , 3015 CN

Haukeland University Hospital, Bergen, Haukeland, Norway

Status

Address

Haukeland University Hospital

Bergen, Haukeland, 5000

Hospital Sant Joan de Deu, Esplugues de Llobregat, Barcelona / Spain, Spain

Status

Address

Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona / Spain, 08950

Madrid, Spain

Status

Address

Hospital General Universitario Gregorio Marañon

Madrid, , 28007

Stockholm, Sweden

Status

Address

Karolinska University Hospital and Institute Solna

Stockholm, , 171 76

St. Michael's Hospital, Bristol, United Kingdom

Status

Address

St. Michael's Hospital

Bristol, , BS2 8EG

Leicester Royal Infirmary, Leicester, United Kingdom

Status

Address

Leicester Royal Infirmary

Leicester, , LE1 5WW

Leicester, United Kingdom

Status

Address

Glenfield Hospital, University Hospitals of Leicester NHS Trust

Leicester, , LE3 9QP

London, United Kingdom

Status

Address

Great Ormond Street Hospital NHS Foundation Trust

London, , WC1N 3JH

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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