Clinical Trial: Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:

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.

Sponsor: NICHD Neonatal Research Network

Current Primary Outcome: Death [ Time Frame: 120 days of age ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: NICHD Neonatal Research Network

Dates:
Date Received: September 15, 2010
Date Started: October 1993
Date Completion:
Last Updated: June 3, 2015
Last Verified: June 2015