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临床试验/NCT04833647
NCT04833647已完成不适用

Influence of Prematurity and Its Respiratory Sequel on Exercise Testing in Childhood

Rambam Health Care Campus0 个研究点目标入组 83 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
83
主要终点
The peak oxygen consumption (VO2max)

研究概览

简要总结

Prospective study comparing hemodynamic and respiratory changes and exercise capacity during Cardio-Pulmonary-Exercise-Testing (CPET) in 4 groups of infants; Three different groups of premature infants and term controls

详细描述

The study population included 4 groups of infants; preterm infants born < 300 weeks' gestation with BPD (i.e. oxygen dependence for at least 28 postnatal days 5), preterm infants born < 300 weeks' gestation without BPD, late preterm infants (born at 340-366 weeks' gestation) and term controls.

Pulmonary function testing and spirometry were measured Participants performed CPET on an electronically braked cycle ergometer. During the exercise testing, serial saturation, heart rate and blood pressure measurements were obtained.

The peak oxygen consumption (VO2max) was measured and served as the primary endpoint of the study.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
7 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 7-10 years of age
  • The ability to ride stationary bicycles as assessed by the parents.

排除标准

  • Immobility
  • An acute febrile or upper respiratory illness in the last 2 weeks
  • The use systemic or inhaled steroids or antiepileptic drugs in the previous month
  • Inhaled bronchodilator use in the previous 24 hours
  • A chronic lung illness (with the exception of BPD and asthma)
  • Congenital cardiac defect (with the exception of atrial septal defect and patent foramen ovale).

结局指标

主要结局

The peak oxygen consumption (VO2max)

时间窗: During the 1 day test

The peak oxygen consumption (VO2max)

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

Ori Hochwald , MD

Director, NICU

Rambam Health Care Campus

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