ENHANCE: A study monitoring how CF complications develop in young children
Details
- Therapeutic approach
- Observational
- Trial status
- Open to recruitment Participating Centres
- Trials Tracker ID
- TT014165
- Last updated
- 15/04/2024
ENHANCE (Establishing Natural History in an Advanced NEW CF Care Era): Understanding how CF complications develop in young children
Study detailsThe ENHANCE study aims to better understand various aspects of the lives and health of children from birth to adulthood with cystic fibrosis (CF).
Though people with CF have more treatment options now, there is still a lot we need to understand about CF in babies and children. This study will monitor how CF complications develop in young children and how different groups of children with CF develop features of the condition. The research will also compare infants (0-1 years) of a similar age with and without CF.
The study will be made up of three groups of participants. Group 1 will include newborn babies diagnosed with CF. Group 2 will include children with CF who are aged between 0 and 5 years when the study begins. Group 3 will include healthy infants who don’t have CF.
CF children who take part will be asked to complete a set of assessments yearly. Some more advanced tests like CT scans, spirometry, and multiple breath washout (MBW) are required as part of this study – these are age dependent assessments so may not be completed by all participants at every visit. Infants in the control group will be able to take part remotely .
ENHANCE will take place over a five-year period initially, with a hope of further long-term extension into the future.
- Phase
- Phase 4
- Length of participation
- 5 years
- Recruitment target
- 350
- CF sponsor
- Royal College of Surgeons in Ireland (RCSI)
Who can take part?
- Age range
- Between 0 months and 5 years old
- Including people
- Newborn babies diagnosed with CF (group 1)
- Children with CF aged 0-5 when the study begins (group 2)
- Infants who don’t have CF (group 3 - the control group)
- Excluding people
- Children or their parents not willing or able to comply with study procedures or assessments
- For groups 1 and 2: children with comorbidities unrelated to CF
- For the control group: children who are carriers of CFTR mutations or have chronic medical or gastrointestinal / liver conditions