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Normal Values of Brain Natriuretic Peptide in Healthy Newborn

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ClinicalTrials.gov Identifier: NCT02574806
Recruitment Status : Completed
First Posted : October 14, 2015
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud

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.

Condition or disease Intervention/treatment
Reference Values of BNP in Healthy Newborn Procedure: Blood sample and BNP measurement

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Study Type : Observational
Actual Enrollment : 167 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Normal Values of Brain Natriuretic Peptide in Healthy Newborn
Study Start Date : April 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

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.




Primary Outcome Measures :
  1. BNP values [ Time Frame: within the first minute after birth and data will present through study completion ]


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Ages Eligible for Study:   up to 1 Minute   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy term newborn obtained by vaginal delivery and/or cesarean section.
Criteria

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.

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
ClinicalTrials.gov Identifier: NCT02574806     History of Changes
Other Study ID Numbers: EBNPRNS01
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Keywords provided by Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud:
BNP
Reference values
Newborn
Ventricular function
Stress
Pediatrics
Biomarkers
Additional relevant MeSH terms:
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Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs