Actively Recruiting
Longitudinal Observational Study on the Course of Cystic Fibrosis Lung Disease in Patients Following Newborn Screening
Led by Heidelberg University · Updated on 2023-11-29
200
Participants Needed
4
Research Sites
991 weeks
Total Duration
On this page
Sponsors
H
Heidelberg University
Lead Sponsor
G
German Center for Lung Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to further characterize early CF lung disease in newborns, infants and toddlers with cystic fibrosis (CF).
CONDITIONS
Official Title
Longitudinal Observational Study on the Course of Cystic Fibrosis Lung Disease in Patients Following Newborn Screening
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed patients with cystic fibrosis meeting at least one of these criteria: sweat chloride 60 mEq/L, two CF-causing mutations in the CFTR gene, or typical changes in transepithelial potential difference
- Early diagnosed (ED): diagnosis by newborn screening or other reasons within first 4 months of life (corrected age for preterms) after January 1, 2006
- Late diagnosed (LD): diagnosis after 4 months of age due to clinical symptoms, after January 1, 2006
You will not qualify if you...
- Patients or parents who do not want to participate or withdraw from the study
- Uncertain diagnosis of cystic fibrosis
- Born before 30th week of gestation
- Long mechanical ventilation in first 3 months of life
- Significant medical disease other than CF that may interfere with study completion
- Previous major surgery except for meconium ileus or intestinal atresia
- Other major organ dysfunction excluding pancreatic or hepatic dysfunction due to CF
- Physical findings compromising safety or study data quality
- Chronic lung disease other than CF (e.g., bronchopulmonary dysplasia)
- History of adverse reactions to sedation medication or known claustrophobia
- Clinically significant upper airway obstruction or severe gastroesophageal reflux delaying sedation procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University Children's Hospital Heidelberg, Cystic Fibrosis Centre
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
2
University Hospital Gießen and Marburg GmbH
Giessen, Hesse, Germany, 35392
Actively Recruiting
3
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany, 30625
Actively Recruiting
4
University Children's Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany, 23538
Actively Recruiting
Research Team
M
Marcus A Mall, MD
CONTACT
M
Mirjam Stahl, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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