Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study



Status:Completed
Conditions:High Blood Pressure (Hypertension), High Blood Pressure (Hypertension), Women's Studies
Therapuetic Areas:Cardiology / Vascular Diseases, Reproductive
Healthy:No
Age Range:Any
Updated:3/24/2019
Start Date:October 1993
End Date:December 1994

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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.

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.

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
We found this trial at
13
sites
New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New Haven, CT
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Dallas, TX
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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920 Madison Ave
Memphis, Tennessee 38163
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Memphis, TN
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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Providence, RI
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Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Albuquerque, NM
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Cincinnati, Ohio 45267
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Cincinnati, OH
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Cleveland, OH
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Palo Alto, California 94304
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Palo Alto, CA
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Washington, District of Columbia 20052
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Washington,
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