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Clinical Trials/NL-OMON31363
NL-OMON31363
Completed
Not Applicable

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

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cystic Fibrosis (CF)
Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Enrollment
45
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational non invasive

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Not specified

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