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Measurements of pulmonary function in children aged 0 - 4 years: children with CF and healthy controls.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON31363
Enrollment
45
Registered
2007-08-01
Start date
2008-07-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis (CF)

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion 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

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 (

Design outcomes

Primary

MeasureTime frame
- Gas mixing measured by the Exhalyzer®D. - Nightly oxygen saturation measured by the Novametrix Model 2001 MARS pulse oximeter. - Nightly cough measured with an audio meter.

Secondary

MeasureTime frame
- Differences between healthy children and children with CF. - Feasability (% successfully performed measurements) of the measurements.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)