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临床试验/NCT02020993
NCT02020993Unknown不适用

The Prognostic Value of Urine NT-ProBNP in Neonatal Respiratory Distress

Ankara University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
severity of respiratory distress

研究概览

简要总结

There is a need for a biochemical marker in addition to clinical condition which will help the physician to understand the clinical progress of the disease.

Urine Nt-proBNP, which does not need any blood sampling and can be collected easily, has not been evaluated for respiratory distress in newborn.

The investigators aim to evaluate the prognostic value of urine NT-proBNP in respiratory diseases in newborns by a controlled trial.

详细描述

Neonatal diseases such as respiratory distress and transient tachypnea of newborn may require high level of intensive care. On the other hand, some minor difficulties in respiration can resolve within hours. Therefore, there is a need for a biochemical marker in addition to clinical condition which will help the physician to understand the clinical progress of the disease.

Serum NT-ProBNP level has been evaluated in transient tachypnea of newborn and found compatible with the clinical progress. Urine NT-proBNP has recently been evaluated in patent ductus arterioses and found compatible with the cardiac progress. However, urine Nt-proBNP, which does not need any blood sampling and can be collected easily, has not been evaluated for respiratory distress in newborn.

The investigators aim to evaluate the prognostic value of urine NT-proBNP in respiratory diseases in newborns by a controlled trial.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
1 Day 至 7 Days(Child)
性别
All
接受健康志愿者

入选标准

  • study group; newborns who are admitted to the neonatal intensive care unit within first 2 days of life and have transient tachypnea of newborn or respiratory distress syndrome signed informed consent form
  • Control Group: Newborns without any respiratory distress

排除标准

  • any cardiac anomaly sepsis acute renal insufficiency syndromic cases low APGAR score at 5th minute (<7) lung malformations no informed consent inability in collection of urine

结局指标

主要结局

severity of respiratory distress

时间窗: 7 days

Severity of respiratory distress will be evaluated by requirement of supportive treatment such as continuous positive airway pressure, need of intubation, mechanical ventilation and duration of support (hours)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Duran Yildiz

MD

Ankara University

研究点 (1)

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