Clinical trial NCT00443859: N-Terminal Pro-brain Natriuretic Peptide Hormone and Persistent Pulmonary Hypertension
Official title: Clinical Significance of N-Terminal Pro-Brain Natriuretic Peptide Levels in Persistent Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Persistent Pulmonary Hypertension of Newborn
Keywords: Persistent Pulmonary Hypertension
N-terminal pro brain natriuretic peptide
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: Thomas Jefferson University
First posted: 2007-03-06
Enrollment: 10
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All infants who are admitted to the NICU with a diagnoses of PPHN.

Brief summary: Babies who are suspected of having persistent pulmonary hypertension (PPHN) will be included in this study. PPHN is a condition in which the blood is restricted from flowing to the lungs in a normal way making it hard for babies to breath and placing strain on the heart. This study will observe whether certain hormones that measure stress (N-terminal pro-brain natriuretic peptide) can help determine how well a baby will do when they have PPHN.

Detailed description: PPHN occurs in infant \> or = 34 weeks gestation and is characterized by an elevation in pulmonary vascular resistance (PVR) and right-to-left shunting of the blood at the atrial, ductal, and pulmonary levels, leading to hypoxemia. Management of these infants is complex (and the clinical course) is often difficult to predict.

Brain natriuretic peptide (BNP) is a cardiac hormone that is secreted from cardiac myocytes and cardiac fibroblasts. Upon activation, the prohormone is cleaved into a biologically active BNP and an inactive N-terminal proBNP (NT-proBNP). BNP and NT-proBNP levels are increasingly being used for diagnostic purpose in adults and have been correlated to adult pulmonary hypertension. Multiples studies have been performed to determine normal values for NT-proBNP in the pediatric population. One study measured NT-proBNP levels in umbilical cord blood during the second trimester and at delivery of uncomplicated pregnancies and determined normal reference values of NT-proBNP. It is thought that NT-proBNP has potential for use in term infants with PPHN.

The objective of this research is to correlate NT-proBNP levels to left ventricular dysfunction in term infants with PPHN. Secondarily, we want to assess the possible use of NT-proBNP to predict response to inhaled nitric oxide and the ability to successfully wean off inhaled nitric oxide.

Eligibility criteria: Inclusion Criteria:

* \>/= 34 weeks gestation at birth
* clinical diagnosis of PPHN

Exclusion Criteria:

* newborns with evidence of structural heart disease, congenital anomalies and prior use of inhaled nitric oxide.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Christiana Hospital / Thomas Jefferson University Hospital
name: Euming Chong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Christiana Hospital / Thomas Jefferson University Hospital
name: Constance Andrejko, DO
role: PRINCIPAL_INVESTIGATOR
References: