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 |
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.
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.
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
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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University of Miami A private research university with more than 15,000 students from around the...
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University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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