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临床试验/NCT02574806
NCT02574806已完成不适用

Normal Values of Brain Natriuretic Peptide in Healthy Newborn

Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud0 个研究点目标入组 167 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
167
主要终点
BNP values

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 1 Minute(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

BNP values

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

次要结局

未报告次要终点

研究者

发起方
Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
申办方类型
Other
责任方
Sponsor

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