Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study

NICHD Neonatal Research Network

Status: Completed

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

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT01203423

M01RR000997 (U.S. NIH Grant/Contract)

U10HD021415 (U.S. NIH Grant/Contract)

U10HD021373 (U.S. NIH Grant/Contract)

U10HD027853 (U.S. NIH Grant/Contract)

U01HD019897 (U.S. NIH Grant/Contract)

M01RR000070 (U.S. NIH Grant/Contract)

M01RR006022 (U.S. NIH Grant/Contract)

U10HD021364 (U.S. NIH Grant/Contract)

U10HD027880 (U.S. NIH Grant/Contract)

U10HD027856 (U.S. NIH Grant/Contract)

U10HD027851 (U.S. NIH Grant/Contract)

NICHD-NRN-0009

M01RR000750 (U.S. NIH Grant/Contract)

U10HD027881 (U.S. NIH Grant/Contract)

U10HD021397 (U.S. NIH Grant/Contract)

M01RR008084 (U.S. NIH Grant/Contract)

U10HD021385 (U.S. NIH Grant/Contract)

U10HD027904 (U.S. NIH Grant/Contract)

U10HD027871 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 385 patients

Sex: All

Ages: Under 7 days old

Volunteers: No 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