Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 7:04 PM
Study NCT ID:
NCT02574806
Status:
COMPLETED
Last Update Posted:
2018-10-19
First Post:
2015-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normal Values of Brain Natriuretic Peptide in Healthy Newborn
Sponsor:
Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
Organization:
Study Overview
Official Title:
Normal Values of Brain Natriuretic Peptide in Healthy Newborn
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: