|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Christiana Care Health Services Thomas Jefferson University Hospital |
|---|---|
| Information provided by: | Christiana Care Health Services |
| ClinicalTrials.gov Identifier: | NCT00443859 |
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: | Cohort, Prospective |
| Official Title: | Clinical Significance of N-Terminal Pro-Brain Natriuretic Peptide Levels in Persistent Pulmonary Hypertension |
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)
|
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 |
All infants who are admitted to the NICU with a diagnoses of PPHN.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Delaware | |
| Christiana Hospital | |
| Newark, Delaware, United States, 19718 | |
| United States, Pennsylvania | |
| Thomas Jefferson University | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Principal Investigator: | Euming Chong, MD | Christiana Hospital / Thomas Jefferson University Hospital |
| Principal Investigator: | Constance Andrejko, DO | Christiana Hospital / Thomas Jefferson University Hospital |
More Information
| Responsible Party: | Christiana Hospital / Thomas Jefferson University Hospital ( Euming Chong, MD ) |
| Study ID Numbers: | CCC 27004 |
| Study First Received: | March 2, 2007 |
| Last Updated: | May 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00443859 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Persistent Pulmonary Hypertension N-terminal pro brain natriuretic peptide |
|
Natriuretic Peptide, Brain Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases Vascular Diseases |
Persistent Fetal Circulation Syndrome Infant, Newborn, Diseases Cardiovascular Agents Hormones Hypertension |
|
Natriuretic Peptide, Brain Physiological Effects of Drugs Vascular Diseases Cardiovascular Agents Pharmacologic Actions Respiratory Tract Diseases Hypertension, Pulmonary |
Natriuretic Agents Therapeutic Uses Lung Diseases Persistent Fetal Circulation Syndrome Infant, Newborn, Diseases Cardiovascular Diseases Hypertension |
