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NCT01203423 Clinical Trial

Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study

Infant, Premature Clinical Trial

— PPHN  

Official title:
Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01203423
Other study ID # NICHD-NRN-0009
Secondary ID U10HD027881U10HD
Status Completed
Phase
First received
Last updated
Start date October 1993
Est. completion date December 1994

Study information
Verified date March 2019
Source NICHD Neonatal Research Network
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 385
Est. completion date December 1994
Est. primary completion date December 1994
Accepts healthy volunteers No
Gender All
Age group N/A to 7 Days
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of New Mexico Albuquerque New Mexico
United States Emory University Atlanta Georgia
United States Cincinnati Children's Medical Center Cincinnati Ohio
United States Case Western Reserve University, Rainbow Babies and Children's Hospital Cleveland Ohio
United States University of Texas Southwestern Medical Center at Dallas Dallas Texas
United States Wayne State University Detroit Michigan
United States Indiana University Indianapolis Indiana
United States University of Tennessee Memphis Tennessee
United States University of Miami Miami Florida
United States Yale University New Haven Connecticut
United States Stanford University Palo Alto California
United States Brown University, Women & Infants Hospital of Rhode Island Providence Rhode Island
United States George Washington University Washington District of Columbia

Sponsors (2)
Lead Sponsor Collaborator
NICHD Neonatal Research Network National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Walsh-Sukys MC, Tyson JE, Wright LL, Bauer CR, Korones SB, Stevenson DK, Verter J, Stoll BJ, Lemons JA, Papile LA, Shankaran S, Donovan EF, Oh W, Ehrenkranz RA, Fanaroff AA. Persistent pulmonary hypertension of the newborn in the era before nitric oxide: — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Death 120 days of age
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