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Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study (PPHN)

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ClinicalTrials.gov Identifier: NCT01203423
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : March 22, 2019
National Center for Research Resources (NCRR)
Information provided by:
NICHD Neonatal Research Network

Brief Summary:
This study was an observational study to estimate the prevalence of Persistent pulmonary hypertension of the newborn (PPHN) among term or near-term infants with severe respiratory disease.

Condition or disease
Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Persistent Fetal Circulation Syndrome Persistent Pulmonary Hypertension of Newborn

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.

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Study Type : Observational
Actual Enrollment : 385 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study
Study Start Date : October 1993
Actual Primary Completion Date : December 1994
Actual Study Completion Date : December 1994

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Death [ Time Frame: 120 days of age ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The infants were screened within the first 24 hours and were followed until enrollment criteria were met or until they reached 7 days of age, whichever occurred first.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203423

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United States, California
Stanford University
Palo Alto, California, United States, 94304
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06504
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20052
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30303
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, Ohio
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States, 45267
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Rhode Island
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
United States, Tennessee
University of Tennessee
Memphis, Tennessee, United States, 38163
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
Sponsors and Collaborators
NICHD Neonatal Research Network
National Center for Research Resources (NCRR)
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Study Director: Michele C. Walsh, MD MS Case Western Reserve University
Principal Investigator: Lu-Ann Papile, MD University of New Mexico
Principal Investigator: Jon E. Tyson, MD MPH University of Texas
Principal Investigator: Barbara J. Stoll, MD Emory University
Principal Investigator: Edward F. Donovan, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Charles R. Bauer, MD University of Miami
Principal Investigator: Raymond Bain, PhD George Washington University
Principal Investigator: Sheldon B. Korones, MD University of Tennessee at Memphis
Principal Investigator: James A. Lemons, MD Indiana University
Principal Investigator: David K. Stevenson, MD Stanford University
Principal Investigator: William Oh, MD Brown University, Womens and Infants Hospital
Principal Investigator: Richard A. Ehrenkranz, MD Yale University
Principal Investigator: Seetha Shankaran, MD Wayne University
Additional Information:
Publications of Results:
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Responsible Party: Michele C. Walsh/ Lead Principal Investigator, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01203423    
Other Study ID Numbers: NICHD-NRN-0009
U10HD027881 ( U.S. NIH Grant/Contract )
U10HD021373 ( U.S. NIH Grant/Contract )
U10HD027851 ( U.S. NIH Grant/Contract )
U10HD027853 ( U.S. NIH Grant/Contract )
U10HD021397 ( U.S. NIH Grant/Contract )
U01HD019897 ( U.S. NIH Grant/Contract )
U10HD021415 ( U.S. NIH Grant/Contract )
U10HD027856 ( U.S. NIH Grant/Contract )
U10HD021364 ( U.S. NIH Grant/Contract )
U10HD027880 ( U.S. NIH Grant/Contract )
U10HD027904 ( U.S. NIH Grant/Contract )
U10HD027871 ( U.S. NIH Grant/Contract )
U10HD021385 ( U.S. NIH Grant/Contract )
M01RR000997 ( U.S. NIH Grant/Contract )
M01RR008084 ( U.S. NIH Grant/Contract )
M01RR000750 ( U.S. NIH Grant/Contract )
M01RR000070 ( U.S. NIH Grant/Contract )
M01RR006022 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Keywords provided by NICHD Neonatal Research Network:
NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)
Persistent Pulmonary Hypertension of Newborn (PPHN)
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Persistent Fetal Circulation Syndrome
Birth Weight
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Body Weight
Infant, Newborn, Diseases