N-Terminal Pro-brain Natriuretic Peptide Hormone and Persistent Pulmonary Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00443859
Recruitment Status : Terminated (Interim analysis showed greater variablility in NT-proBNP findings than anticipated.)
First Posted : March 6, 2007
Last Update Posted : July 11, 2016
Thomas Jefferson University
Information provided by (Responsible Party):
Christiana Care Health Services

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.

Condition or disease
Persistent Pulmonary Hypertension of Newborn

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.

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Significance of N-Terminal Pro-Brain Natriuretic Peptide Levels in Persistent Pulmonary Hypertension
Study Start Date : February 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Infants with persistent pulmonary hypertension (PPHN)

Biospecimen Retention:   Samples Without DNA
Whole blood

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All infants who are admitted to the NICU with a diagnoses of PPHN.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00443859

United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19718
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Christiana Care Health Services
Thomas Jefferson University
Principal Investigator: Euming Chong, MD Christiana Hospital / Thomas Jefferson University Hospital
Principal Investigator: Constance Andrejko, DO Christiana Hospital / Thomas Jefferson University Hospital

Responsible Party: Christiana Care Health Services Identifier: NCT00443859     History of Changes
Other Study ID Numbers: CCC 27004
First Posted: March 6, 2007    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: May 2009

Keywords provided by Christiana Care Health Services:
Persistent Pulmonary Hypertension
N-terminal pro brain natriuretic peptide

Additional relevant MeSH terms:
Hypertension, Pulmonary
Persistent Fetal Circulation Syndrome
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Infant, Newborn, Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs