About this trial
The purpose of this study is to further characterize early CF lung disease in newborns, infants and toddlers with cystic fibrosis (CF).
Eligibility criteria
Qualifiers
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.
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.
Disqualifiers
Preterms <30th week of gestation
Longer period of mechanical ventilation in first 3 months of life
A significant medical disease or condition other than CF likely to interfere with the child's ability to complete the entire protocol
Previous major surgery except for meconium ileus or atresia of the intestine
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Heidelberg University
Lead sponsor
German Center for Lung Research
Collaborator