Understanding how early lung health and infections affect lung disease in children with cystic fibrosis
Impact of Early Lung Physiology, Viral Infections and the Microbiota on the Development and Progression of Lung Disease in Children With Cystic Fibrosis
This study looks at how lung health and infections in young children with cystic fibrosis affect their lung growth and disease progression to find ways to help them breathe better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 0 Years to 18 Years |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT04026360 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data on microbiological factors and lung function parameters in infants and children diagnosed with cystic fibrosis (CF). It focuses on the impact of respiratory viral infections and the microbiome on lung growth and development. By assessing lung function through various methods such as spirometry and lung-MRI, the study seeks to identify early predictors of disease progression in CF. The findings could lead to targeted early interventions to improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are infants and children up to 18 years old with a confirmed diagnosis of cystic fibrosis.
Not a fit: Patients requiring respiratory support for more than three days or those with severe malformations or other significant diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights that lead to improved early interventions for children with cystic fibrosis, potentially enhancing their lung health and overall survival.
How similar studies have performed: Other studies have explored the relationship between lung function and microbiota in cystic fibrosis, indicating that this approach has potential but may also include novel aspects.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants with a confirmed diagnosis of CF by NBS * Age \<=18 years * Written informed consent by patient and/or parent Exclusion Criteria: * Need for respiratory support for more than three days * Severe malformations or known diseases other than CF * Maternal drug abuse * Known severe maternal disease * Severe Problems of communication * Pacemaker, continuous glucose monitor
Where this trial is running
Bern
- University Children's Hospital Bern — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Philipp Latzin, MD PhD — University Children's Hospital Bern
- Study coordinator: Philipp Latzin, MD PhD
- Email: philipp.latzin@insel.ch
- Phone: 0041 31 632 94 93
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.