Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-02-05 @ 5:43 PM
Study NCT ID:
NCT02574806
Status:
COMPLETED
Last Update Posted:
2018-10-19
First Post:
2015-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normal Values of Brain Natriuretic Peptide in Healthy Newborn
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-18', 'studyFirstSubmitDate': '2015-10-07', 'studyFirstSubmitQcDate': '2015-10-10', 'lastUpdatePostDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BNP values', 'timeFrame': 'within the first minute after birth and data will present through study completion'}]}, 'conditionsModule': {'keywords': ['BNP', 'Reference values', 'Newborn', 'Ventricular function', 'Stress', 'Pediatrics', 'Biomarkers'], 'conditions': ['Reference Values of BNP in Healthy Newborn']}, 'referencesModule': {'references': [{'pmid': '30337314', 'type': 'DERIVED', 'citation': 'Rodriguez D, Garcia-Rivas G, Laresgoiti-Servitje E, Yanez J, Torre-Amione G, Jerjes-Sanchez C. B-type natriuretic peptide reference interval of newborns from healthy and pre-eclamptic women: a prospective, multicentre, cross-sectional study. BMJ Open. 2018 Oct 17;8(10):e022562. doi: 10.1136/bmjopen-2018-022562.'}], 'seeAlsoLinks': [{'url': 'https://bmjopen.bmj.com/content/8/10/e022562', 'label': 'B-type natriuretic peptide reference interval of newborns from healthy and pre-eclamptic women: a prospective, multicentre, cross-sectional study'}]}, 'descriptionModule': {'briefSummary': 'Brain natriuretic peptide (BNP) is an important tool for diagnosis, risk stratification and prognosis in pediatric patients with heart failure1. In newborn, after delivery, the BNP plays an important role in cardiopulmonary hemodynamics by stimulating vasodilatation and diuresis. The gradual decrease in pulmonary pressure and the initiation of diuresis as expression of renal maturity could explain the subsequent decrease in serum values. This would suggest that, in healthy newborns, BNP values should be found within a given ranges. However, the evidence suggests an important variability in BNP values 2 - 4. In the other hand, in the newborn with respiratory distress BNP could have a high negative predictive value to rule out acute myocardial processes, as responsible for clinical deterioration, from infectious, metabolic or respiratory processes; with a potential of improvement in medical care. Even the increased use of this biomarker in clinical practice, until our knowledge, BNP normal values remain unknown in the healthy newborn. Therefore, the investigators performed a pioneer study to establish normal values in healthy newborn population. Multi-center, prospective and observational study was carried out. Objective: To establish normal BNP values in healthy newborn.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Minute', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy term newborn obtained by vaginal delivery and/or cesarean section.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy mother with pregnancy at term (38 to 42 gestational weeks) with adequate prenatal care.\n* newborns with Apgar score ≥ 7 at 0 and 5 minutes respectively.\n\nExclusion Criteria:\n\n* newborns of mothers with pregnancy-associated diseases.\n* newborns with chromosomopathies detected during the antenatal care and newborns with signs of cardiac and/or respiratory compromise.'}, 'identificationModule': {'nctId': 'NCT02574806', 'briefTitle': 'Normal Values of Brain Natriuretic Peptide in Healthy Newborn', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud'}, 'officialTitle': 'Normal Values of Brain Natriuretic Peptide in Healthy Newborn', 'orgStudyIdInfo': {'id': 'EBNPRNS01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy newborn', 'description': 'Healthy newborn at term of healthy mother.', 'interventionNames': ['Procedure: Blood sample and BNP measurement']}, {'label': 'Preeclamptic newborn', 'description': 'Newborn at term of mother with pre-eclampsia with severity features.', 'interventionNames': ['Procedure: Blood sample and BNP measurement']}], 'interventions': [{'name': 'Blood sample and BNP measurement', 'type': 'PROCEDURE', 'description': 'Blood sample of umbilical artery from umbilical cord immediately after birth.', 'armGroupLabels': ['Healthy newborn', 'Preeclamptic newborn']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}