Normal Values of Brain Natriuretic Peptide in Healthy Newborn

October 18, 2018 updated by: Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

167

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 minute (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy term newborn obtained by vaginal delivery and/or cesarean section.

Description

Inclusion Criteria:

  • healthy mother with pregnancy at term (38 to 42 gestational weeks) with adequate prenatal care.
  • newborns with Apgar score ≥ 7 at 0 and 5 minutes respectively.

Exclusion Criteria:

  • newborns of mothers with pregnancy-associated diseases.
  • newborns with chromosomopathies detected during the antenatal care and newborns with signs of cardiac and/or respiratory compromise.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy newborn
Healthy newborn at term of healthy mother.
Procedure: Blood sample and BNP measurement
Blood sample of umbilical artery from umbilical cord immediately after birth.
Preeclamptic newborn
Newborn at term of mother with pre-eclampsia with severity features.
Procedure: Blood sample and BNP measurement
Blood sample of umbilical artery from umbilical cord immediately after birth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BNP values
Time Frame: within the first minute after birth and data will present through study completion
within the first minute after birth and data will present through study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

October 7, 2015

First Submitted That Met QC Criteria

October 10, 2015

First Posted (Estimate)

October 14, 2015

Study Record Updates

Last Update Posted (Actual)

October 19, 2018

Last Update Submitted That Met QC Criteria

October 18, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EBNPRNS01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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