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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorHeidelberg University

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

200 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Heidelberg University

Lead sponsor

German Center for Lung Research

Collaborator