Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-26 @ 1:06 PM
Study NCT ID:
NCT00443859
Status:
TERMINATED
Last Update Posted:
2016-07-11
First Post:
2007-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
N-Terminal Pro-brain Natriuretic Peptide Hormone and Persistent Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010547', 'term': 'Persistent Fetal Circulation Syndrome'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Interim analysis showed greater variablility in NT-proBNP findings than anticipated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-07', 'studyFirstSubmitDate': '2007-03-02', 'studyFirstSubmitQcDate': '2007-03-02', 'lastUpdatePostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Persistent Pulmonary Hypertension', 'N-terminal pro brain natriuretic peptide'], 'conditions': ['Persistent Pulmonary Hypertension of Newborn']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nBrain 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All infants who are admitted to the NICU with a diagnoses of PPHN.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>/= 34 weeks gestation at birth\n* clinical diagnosis of PPHN\n\nExclusion Criteria:\n\n* newborns with evidence of structural heart disease, congenital anomalies and prior use of inhaled nitric oxide.'}, 'identificationModule': {'nctId': 'NCT00443859', 'briefTitle': 'N-Terminal Pro-brain Natriuretic Peptide Hormone and Persistent Pulmonary Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Christiana Care Health Services'}, 'officialTitle': 'Clinical Significance of N-Terminal Pro-Brain Natriuretic Peptide Levels in Persistent Pulmonary Hypertension', 'orgStudyIdInfo': {'id': 'CCC 27004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PPHN', 'description': 'Infants with persistent pulmonary hypertension (PPHN)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Hospital', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Euming Chong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Christiana Hospital / Thomas Jefferson University Hospital'}, {'name': 'Constance Andrejko, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Christiana Hospital / Thomas Jefferson University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christiana Care Health Services', 'class': 'OTHER'}, 'collaborators': [{'name': 'Thomas Jefferson University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}