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临床试验/NCT01057472
NCT01057472已完成不适用

Repeatability and Feasibility of Infant Spirometry

Haukeland University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年1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
30
试验地点
1
主要终点
Repeatability of measurements performed by two different nurses before and after a meal in term babies (10), preterm babies before discharge (10) and preterm babies weighing approximately 1500 grams

研究概览

简要总结

This is a study examining repeatability and feasibility of a new method for measurement of lung function in babies. A flexible vest is placed around the torso of the baby, and changes in tidal volume and flow is measured. The study will enable a better understanding of the usefulness of this equipment in a neonatal intensive care unit. The equipment is made by VOLUSENSE Norway AS, and marketed under the name FloRight. The equipment is owned by Volusense Norway AS during the study period.

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
4 Weeks 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Being a Term born and preterm born babies

排除标准

  • Being in an unstable clinical condition

结局指标

主要结局

Repeatability of measurements performed by two different nurses before and after a meal in term babies (10), preterm babies before discharge (10) and preterm babies weighing approximately 1500 grams

时间窗: Before and after a meal

次要结局

  • Feasibility of the measurements in the NICU(1 year)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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