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
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.
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