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临床试验/NCT04483492
NCT04483492Unknown不适用

Direct Effect of Caffeine on Diaphragmatic Muscles

Hacettepe University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2019年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
56
试验地点
1
主要终点
diphragmatic contractility

研究概览

简要总结

The mechanism of methylxanthines is thought to increase chemoreceptor responsiveness to CO2 in central nervous system. Besides, effect of methylxanthines on diaphragmatic contractility has also been found in experimental studies. A study of premature newborns has showed caffeine increase diaphragmatic activity and tidal volume. But, there is limited data about caffeine direct effect on diaphragma.

Objective: The investigators aimed to show the direct effect of caffeine on diphragmatic contractility.

Method: The babies under 32 weeks with respiratory support, are being enrolled in this study if caffeine treatment is decided to receive. Evaluation of muscle contraction is being made by ultrasound before and 30 minutes after caffeine loading dose. Right and left sides of diaphragm thickness are being measured by two clinicians on B mode ultrasound by anterior subcostal view. The velocity before and after caffeine administration will be calculated, dividing excursion frequency (parameter) for inspiratory time. Movement of the diaphragm at inspiratory and expiratory phases are also observed on M mode and the difference between the two phases are measured.

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
1 Day 至 7 Days(Child)
性别
All
接受健康志愿者

入选标准

  • newborns under 32 weeks with respiratory support
  • caffeine is decided to give

排除标准

  • babies with congenital malformations

研究组 & 干预措施

1

newborns under 32 weeks with respiratory support if they are decided to start caffeine treatment

干预措施: Caffeine citrate (Drug)

结局指标

主要结局

diphragmatic contractility

时间窗: 30 minutes

diphragmatic contractility measured by ultrasonographic evaluation

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

H. Tolga Çelik

Principal Investigator

Hacettepe University

研究点 (1)

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