Normal Values of Brain Natriuretic Peptide in Healthy Newborn

NCT02574806 | Completed

• 1 other identifier: EBNPRNS01
• Study Type: observational
• Target: 167
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Reference Values of BNP in Healthy Newborn

Keywords

BNP; Reference values; Newborn; Ventricular function; Stress; Pediatrics; Biomarkers

Outcome Measures

Primary Outcomes (1)

• BNP values

  within the first minute after birth and data will present through study completion

Study Arms (2)

Healthy newborn

Healthy newborn at term of healthy mother.

Procedure: Blood sample and BNP measurement

Preeclamptic newborn

Newborn at term of mother with pre-eclampsia with severity features.

Procedure: Blood sample and BNP measurement

Interventions

Blood sample and BNP measurement PROCEDURE

Blood sample of umbilical artery from umbilical cord immediately after birth.

Healthy newborn; Preeclamptic newborn

Eligibility Criteria

• Age: Up to 1 Minute
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 30337314 DERIVED

Related Links

• B-type natriuretic peptide reference interval of newborns from healthy and pre-eclamptic women: a prospective, multicentre, cross-sectional study

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 14, 2015
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: October 19, 2018

Record last verified: 2018-10