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Observational study. Metingen naar de functie van de longen bij kinderen van 0 t/m 4 jaar oud: kinderen met CF en gezonde kinderen.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON22670
Enrollment
45
Registered
2007-09-03
Start date
2007-10-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Cystic fibrosis, CF.

Interventions

No interventions, this is an observational study.

Sponsors

H.A.W.M. Tiddens, M.D., PhD. and ms. E.M. Bakker, M.D.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria for children with CF: 1. Age 0 – 4 years (0 up to and including 4 years); 2. Diagnosis of CF confirmed by sweat-test and/or DNA analysis and/or electro physiology testing (nasal potential difference measurement or intestinal current measurement); 3. Clinically stable patients: no hospital admission and no need for an antibiotic course for at least 4 weeks prior to enrolment in the study; 4. No signs of acute viral respiratory infection in the period from 1 week (7 days) before the measurement until the day of the measurement. An acute viral respiratory infection is defined as a combination of the following symptoms: rhinitis; pharyngitis; cough; headache; fever; 5. Signed written informed consent. Inclusion criteria for healthy children: 1. Age 0-4 years; 2. No use of an antibiotic course (for pulmonary reasons) for at least 4 weeks prior to enrolment in the study; 3. No signs of respiratory infection in the period from 1 week (7 days) before the measurement until the day of the measurement; 4. Signed written informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria for children with CF: 1. Medical conditions that might affect the measurements (e.g. cardiac problems that can influence saturation); 2. Pulmonary exacerbation at the time of the study. Exclusion criteria for healthy children: 1. Medical conditions that might affect the measurements (e.g. cardiac problems that can influence saturation); 2. History of pulmonary diseases such as asthma, BPD, airway malacia; 3. Current use of pulmonary drugs; 4. History of premature birth; 5. ENT related interventions in recent history (< 1 month), such as tonsillectomy, antibiotics for ENT infections, grommets, etc.

Design outcomes

Primary

MeasureTime frame
Measurements of overnight SpO2, gas mixing and overnight cough.

Contacts

Public ContactE.M. Bakker

Erasmus Medical Center, Sophia Children’s Hospital, Department of Pediatric Pulmonology (room Sb-2666) Dr. Molenwaterplein 60

e.bakker@erasmusmc.nl+31 (0)10 4636683

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)