Status:
COMPLETED
Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study
Lead Sponsor:
NICHD Neonatal Research Network
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Infant, Newborn
Infant, Low Birth Weight
Eligibility:
All Genders
Up to 7 years
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.
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 wit...
Eligibility Criteria
Inclusion
- \>= 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
- \>7 days of age
Key Trial Info
Start Date :
October 1 1993
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 1994
Estimated Enrollment :
385 Patients enrolled
Trial Details
Trial ID
NCT01203423
Start Date
October 1 1993
End Date
December 1 1994
Last Update
March 22 2019
Active Locations (13)
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1
Stanford University
Palo Alto, California, United States, 94304
2
Yale University
New Haven, Connecticut, United States, 06504
3
George Washington University
Washington D.C., District of Columbia, United States, 20052
4
University of Miami
Miami, Florida, United States, 33136