Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01203423

Acronym

PPHN

Enrollment

385

Registered

2010-09-16

Start date

1993-10-31

Completion date

1994-12-31

Last updated

2019-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Prematurity, Persistent Pulmonary Hypertension of Newborn (PPHN)

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 7 Days

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Death	120 days of age

Countries

United States

Outcome results