Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study

Completed

• Conditions: Infant, Small for Gestational Age; Infant, Premature; Persistent Pulmonary Hypertension of Newborn; Infant, Newborn; Infant, Low Birth Weight; Persistent Fetal Circulation Syndrome

• Registration Number: NCT01203423
• Lead Sponsor: NICHD Neonatal Research Network

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 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.

Study Timeline

• Study Start: 1993-10
• Primary Completion: 1994-12
• Study Completion: 1994-12
• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-16
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 385

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death	120 days of age

Trial Locations

Locations (13)

Stanford University; 🇺🇸 Palo Alto, California, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

George Washington University; 🇺🇸 Washington, District of Columbia, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, 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

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