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Neus(bijholten)problemen bij kinderen met Cystic Fibrosis.


- candidate number15374
- NTR NumberNTR4161
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-sep-2013
- Secondary IDsNL43794.098.13 
- Public TitleNeus(bijholten)problemen bij kinderen met Cystic Fibrosis.
- Scientific TitleSinonasal pathology in children with Cystic Fibrosis
- ACRONYMSINAS study
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedCystic Fibrosis (CF)
- Inclusion criteria- Confirmed diagnosis of Cystic Fibrosis based on genotyping or a positive sweat test
- Age 0-<18 years
- Exclusion criteria- Gross inmmunodeficiency (congenital or acquired)
- Congenital mucociliary problems other than CF (e.g. Primary Ciliairy Diskinesia)
- ASA syndome (Samter's trias; nasal polyps, asthma and aspirin sensitivity)
- Intranasal neoplasia
- Systemic vasculitis and granulomatous diseases (e.g. M. Wegener, sarcoidosis, Churg-Strauss syndrome)
- Recently (within 1 month) CT-sinus performed
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-okt-2013
- planned closingdate1-okt-2014
- Target number of participants60
- InterventionsObservational study:
- CT-sinus
- Nasopharyngeal swab
- Lower airway culture
- Primary outcomeOpacification of sinuses on CT-scan (Lund-Mackay score)
- Secondary outcome- Development of paranasasl sinuses
- Severity of CF
- Onset of sinonasa pathology
- Symptoms of sinonasal disease
- Outcome of nasopharyngeal swab
- Anatomic variations in sinonasal area
- Outcome of lower airway culture
- TimepointsStudy procedures performed in one day
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. Maaike Berkhout
- CONTACT for SCIENTIFIC QUERIESDrs. Maaike Berkhout
- Sponsor/Initiator Haga Hospital
- Funding
(Source(s) of Monetary or Material Support)
Lungfund Haga Teaching Hospital
- PublicationsN/A
- Brief summaryAdult CF patients often display signs of chronic rhinosinusitis on a CT-scan. However, to date the onset and the pathogenesis of this sinonasal pathology in Cystic Fibrosis in unclear. By studying children with CF from birth untill 18 years, more knowledge on the onset of sinonasal disease can be gathered. More knowledge on the pathogenesis of sinonasal disease is necessary to develop an accurate treatment protocol for this pathology. Early interventions may prevent a chronic course of sinonasal pathology and eventually less complaints in adult life.
- Main changes (audit trail)
- RECORD5-sep-2013 - 29-sep-2013


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