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

This study has been terminated.
(Interim analysis showed greater variablility in NT-proBNP findings than anticipated.)
Sponsor:
Collaborator:
Thomas Jefferson University
Information provided by:
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00443859
First received: March 2, 2007
Last updated: May 1, 2009
Last verified: May 2009
  Purpose

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
Persistent Pulmonary Hypertension of Newborn

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Significance of N-Terminal Pro-Brain Natriuretic Peptide Levels in Persistent Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by Christiana Care Health Services:

Biospecimen Retention:   Samples Without DNA

Whole blood


Enrollment: 10
Study Start Date: February 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
PPHN
Infants with persistent pulmonary hypertension (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

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All infants who are admitted to the NICU with a diagnoses of PPHN.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443859

Locations
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
Investigators
Principal Investigator: Euming Chong, MD Christiana Hospital / Thomas Jefferson University Hospital
Principal Investigator: Constance Andrejko, DO Christiana Hospital / Thomas Jefferson University Hospital
  More Information

No publications provided

Responsible Party: Euming Chong, MD, Christiana Hospital / Thomas Jefferson University Hospital
ClinicalTrials.gov Identifier: NCT00443859     History of Changes
Other Study ID Numbers: CCC 27004
Study First Received: March 2, 2007
Last Updated: May 1, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014