- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01203423
Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study (PPHN)
Study Overview
Status
Detailed Description
The optimal approach to the treatment of PPHN remains controversial. In 1978, hyperventilation was advocated for the treatment of PPHN. Newer therapies such as alkali infusion have been introduced without the support of randomized trial. In addition, in 1993, large controlled trials of inhaled nitric oxide were in the planning stages. There is a lack of knowledge about how these diverse management styles impact patient outcome.
Given the large number of treatments used in neonates with PPHN, we wished to document treatment of PPHN and outcomes of those treatments. Therefore, we performed a prospective, observational study to document prevalence of PPHN, the treatments and outcomes in a large population of infants treated at the 12 centers of the National Institute of Child Health and Human Development (NICHD) Neonatal Research Network. Further, we sought to compare treatment with hyperventilation to treatment with alkali infusion.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Palo Alto, California, United States, 94304
- Stanford University
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Connecticut
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New Haven, Connecticut, United States, 06504
- Yale University
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District of Columbia
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Washington, District of Columbia, United States, 20052
- George Washington University
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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Georgia
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Atlanta, Georgia, United States, 30303
- Emory University
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University
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Michigan
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Detroit, Michigan, United States, 48201
- Wayne State University
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New Mexico
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Albuquerque, New Mexico, United States, 87131
- University of New Mexico
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Ohio
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Cincinnati, Ohio, United States, 45267
- Cincinnati Children's Medical Center
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Cleveland, Ohio, United States, 44106
- Case Western Reserve University, Rainbow Babies and Children's Hospital
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Rhode Island
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Providence, Rhode Island, United States, 02905
- Brown University, Women & Infants Hospital of Rhode Island
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Tennessee
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Memphis, Tennessee, United States, 38163
- University of Tennessee
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Texas
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Dallas, Texas, United States, 75235
- University Of Texas Southwestern Medical Center At Dallas
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- >= 34 weeks gestational age
- On mechanical ventilation and/or fraction of inspired oxygen >0.50; and
- Had documented pulmonary artery hypertension as defined by either two-dimensional echocardiographic evidence of elevated pulmonary pressure (judged by right to left or bidirectional shunt), or a preductal to postductal oxygen gradient >20 mm Hg
Exclusion Criteria:
- >7 days of age
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Death
Time Frame: 120 days of age
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120 days of age
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Michele C. Walsh, MD MS, Case Western Reserve University
- Principal Investigator: Seetha Shankaran, MD, Wayne University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NICHD-NRN-0009
- U10HD021364 (U.S. NIH Grant/Contract)
- U10HD021373 (U.S. NIH Grant/Contract)
- U10HD021385 (U.S. NIH Grant/Contract)
- U10HD027851 (U.S. NIH Grant/Contract)
- U10HD027853 (U.S. NIH Grant/Contract)
- U10HD027856 (U.S. NIH Grant/Contract)
- U10HD027871 (U.S. NIH Grant/Contract)
- U10HD027880 (U.S. NIH Grant/Contract)
- U10HD027904 (U.S. NIH Grant/Contract)
- U01HD019897 (U.S. NIH Grant/Contract)
- U10HD021415 (U.S. NIH Grant/Contract)
- U10HD027881 (U.S. NIH Grant/Contract)
- M01RR008084 (U.S. NIH Grant/Contract)
- M01RR006022 (U.S. NIH Grant/Contract)
- M01RR000750 (U.S. NIH Grant/Contract)
- M01RR000070 (U.S. NIH Grant/Contract)
- M01RR000997 (U.S. NIH Grant/Contract)
- U10HD021397 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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