Status:
NOT_YET_RECRUITING
ENHANCE- Establishing Natural History in an Advanced New CF Care Era
Lead Sponsor:
Royal College of Surgeons, Ireland
Collaborating Sponsors:
University Hospital of Limerick
Cork University Hospital
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
1-5 years
Brief Summary
Measured outcomes for people with CF have improved dramatically over the last 20 years, even prior to the widespread introduction of cystic fibrosis transmembrane conductance regulator (CTFR) modulato...
Eligibility Criteria
Inclusion
- Children with CF attending one of the study centres and fulling one of the following:
- Newborn infant diagnoses with cystic fibrosis through newborn screening (excludes children with an uncertain diagnosis), or having 2 documented CF disease causing mutations.
- Children with CF (sweat chloride\>60mmol/L or 2 CF disease causing mutations) aged 0-6 at study initiation
- Healthy control infants without CF
Exclusion
- Children or their parents not willing or able to complete with study procedures or assessments.
- Co-morbidities in groups 1 and 2, unrelated to CF, that in the opinion of the investigator would substantially impact on study measurements and unduly affect the veracity of the outcome data, for example a diagnosis of inflammatory bowel disease or extreme prematurity.
- Children in the control group who are carriers of CFTR mutations or have chronic medical or GI/Liver conditions that in the opinion of the investigator would unduly affect the veracity of the outcome data.
- We will not exclude someone who subsequently joins a CF Investigational drug trial if they are happy to continue, but if possible, will time their annual ENHANCE data collection to fall outside the time period of any experimental study drug administration
Key Trial Info
Start Date :
October 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT05986045
Start Date
October 1 2023
End Date
September 30 2028
Last Update
August 31 2023
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