NCT01203423

Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 385 (actual)
• Sponsor: NICHD Neonatal Research Network · Network
• Sex: All
• Age: 7 Days
• Healthy volunteers: Not accepted

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.

Conditions

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

Timeline

• Start date: 1993-10-01
• Primary completion: 1994-12-01
• Completion: 1994-12-01
• First posted: 2010-09-16
• Last updated: 2019-03-22

Locations

13 sites across 1 country: United States