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

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
Other Locations
Germany
University Hospital Gießen and Marburg GmbH
RECRUITING
Giessen
Medizinische Hochschule Hannover
RECRUITING
Hanover
University Children's Hospital Heidelberg, Cystic Fibrosis Centre
RECRUITING
Heidelberg
University Children's Hospital Schleswig-Holstein
RECRUITING
Lübeck
Contact Information
Primary
Marcus A Mall, MD
Marcus.Mall@med.uni-heidelberg.de
+49 6221 56 4502
Backup
Mirjam Stahl, MD
Mirjam.Stahl@med.uni-heidelberg.de
+49 6221 56 37049
Time Frame
Start Date: 2011-12
Estimated Completion Date: 2030-12
Participants
Target number of participants: 200
Treatments
Early diagnosed (ED)
Children diagnosed with CF in the first 4 months of life.
Late diagnosed (LD)
Children diagnosed with CF after the first 4 months of life.
Related Therapeutic Areas
Sponsors
Collaborators: German Center for Lung Research
Leads: Heidelberg University

This content was sourced from clinicaltrials.gov