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Recruiting NCT02270476

Longitudinal Observational Study on the Course of Cystic Fibrosis Lung Disease in Patients Following Newborn Screening

Trial Parameters

Condition Cystic Fibrosis Lung Disease
Sponsor Heidelberg University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2011-12
Completion 2030-12

Brief Summary

The purpose of this study is to further characterize early CF lung disease in newborns, infants and toddlers with cystic fibrosis (CF).

Eligibility Criteria

Inclusion Criteria: 1. Newly diagnosed patients with Cystic Fibrosis (CF). Diagnosis of CF: at least one of the following three international accepted criteria is fulfilled: i) sweat chloride ≥ 60mEq/L and/or ii) 2 CF-causing mutations in the CFTR gene and/or iii) changes typical for CF in the transepithelial potential difference in nasal or rectal epithelium. 2. Age and mode of diagnosis: * Early diagnosed (ED): Initial diagnosis following CF-NBS or for other reasons in the first 4 months of life (in preterms corrected age of 4 months) after January 1st, 2006. Other reasons could be prenatal diagnostics, meconium ileus or positive family history. * Late diagnosed (LD): Diagnosed after the fourth month of life due to clinical symptoms; initial diagnosis after January 1st, 2006. Exclusion Criteria: All patients are excluded who themselves or whose parents do not want to participate or that withdraw from the study; or those in whom the diagnosis of CF is unsure. Further exclusion criteri

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