Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study
NCT ID: NCT01203423
Last Updated: 2019-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
385 participants
OBSERVATIONAL
1993-10-31
1994-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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National Center for Research Resources (NCRR)
NIH
NICHD Neonatal Research Network
NETWORK
Responsible Party
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Case Western Reserve University
Principal Investigators
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Michele C. Walsh, MD MS
Role: STUDY_DIRECTOR
Case Western Reserve University
Lu-Ann Papile, MD
Role: PRINCIPAL_INVESTIGATOR
University of New Mexico
Jon E. Tyson, MD MPH
Role: PRINCIPAL_INVESTIGATOR
University of Texas
Barbara J. Stoll, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Edward F. Donovan, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Charles R. Bauer, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Raymond Bain, PhD
Role: PRINCIPAL_INVESTIGATOR
George Washington University
Sheldon B. Korones, MD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee at Memphis
James A. Lemons, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
David K. Stevenson, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
William Oh, MD
Role: PRINCIPAL_INVESTIGATOR
Brown University, Womens and Infants Hospital
Richard A. Ehrenkranz, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Seetha Shankaran, MD
Role: PRINCIPAL_INVESTIGATOR
Wayne University
Locations
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Stanford University
Palo Alto, California, United States
Yale University
New Haven, Connecticut, United States
George Washington University
Washington D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
Wayne State University
Detroit, Michigan, United States
University of New Mexico
Albuquerque, New Mexico, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
University of Tennessee
Memphis, Tennessee, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Countries
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References
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Walsh-Sukys MC, Tyson JE, Wright LL, Bauer CR, Korones SB, Stevenson DK, Verter J, Stoll BJ, Lemons JA, Papile LA, Shankaran S, Donovan EF, Oh W, Ehrenkranz RA, Fanaroff AA. Persistent pulmonary hypertension of the newborn in the era before nitric oxide: practice variation and outcomes. Pediatrics. 2000 Jan;105(1 Pt 1):14-20. doi: 10.1542/peds.105.1.14.
Related Links
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NICHD Neonatal Research Network
Other Identifiers
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NICHD-NRN-0009
Identifier Type: -
Identifier Source: org_study_id
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