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临床试验/NL-OMON31363
NL-OMON31363已完成不适用

Measurements of pulmonary function in children aged 0 - 4 years: children with CF and healthy controls. - FLY: Function measurements of the Lungs in Young children

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 45 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
2 至 11(—)

入选标准

  • Children with CF:
  • - Age 0-4 years; (0 years up to and including 4 years)
  • - Diagnosis of CF confirmed by sweat-test and/or DNA analysis and/or electro physiology testing (nasal potential difference measurement or intestinal current measurement);
  • - Clinically stable patients: no hospital admission and no need for an antibiotic course for at least 4 weeks prior to enrolment in the study;
  • - No signs of (viral) respiratory infection in the period from 1 week (7 days) before the measurement until the day of the measurement. (Viral) respiratory infection is defined as a combination of the following symptoms: rhinitis; pharyngitis; cough; headache; fever;
  • - Signed written informed consent.;Healthy controls:
  • - Age 0-4 years;
  • - No use of an antibiotic course (for pulmonary reasons) for at least 4 weeks prior to enrolment in the study;
  • - No signs of respiratory infection in the period from 1 week (7 days) before the measurement until the day of the measurement (definition of viral infection see children with CF);
  • - Signed written informed consent.

排除标准

  • All study participants:
  • - Medical conditions that might affect the measurements (e.g. cardiac problems that can influence saturation, BPD (bronchopulmonary dysplasia)) that can influence LCI, etc.).;Children with CF:
  • - Pulmonary exacerbation at the time of the study.;Healthy controls:
  • - History of pulmonary diseases such as asthma, BPD, airway malacia;
  • - Current use of pulmonary drugs;
  • - History of premature birth (before 37 weeks gestation);
  • - ENT related interventions in recent history (< 1 month), such as tonsillectomy, antibiotics for ENT infections, grommets, etc.

研究者

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