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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Page 1 of 4 (13 locations)

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