ENHANCE: A study monitoring how CF complications develop in young children

Details

CTAP badge
Therapeutic approach
Observational
Trial status
Open to recruitment Participating Centres
Trials Tracker ID
TT014165
Last updated
15/04/2024

Full title

ENHANCE (Establishing Natural History in an Advanced NEW CF Care Era): Understanding how CF complications develop in young children

Study details

The 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
Get in touch

CF centres running this trial

Recruiting

Cardiff - Noah's Ark Children's Hospital for Wales

CTAP centre
NHS Trust
Cardiff and Vale University Health Board
Address
Children and Young Adults Research Unit
Heath Park
CF14 4XW
Recruitment starts
Recruitment ends
Trial Coordinators
Catherine Joyce
Recruiting

Edinburgh - Royal Hospital for Children and Young People

CTAP centre
NHS Trust
NHS Lothian
Address
50 Little France Crescent
EH16 4TJ
Recruitment starts
Recruitment ends
Trial Coordinators
Debbie Miller
Recruiting

Liverpool - Alder Hey Children's Hospital

CTAP centre
NHS Trust
Alder Hey Children's NHS Foundation Trust
Address
Eaton Road
West Derby
L12 2AP
Recruitment starts
Recruitment ends
Trial Coordinators
Victoria King
Recruiting

Royal Belfast Hospital for Sick Children

CTAP centre
NHS Trust
Belfast Health & Social Care Trust
Address
180 Falls Road
BT12 6BE
Recruitment starts
Recruitment ends
Trial Coordinators
Catherine McNeill
Michelle Spence
Recruiting

Royal Brompton Hospital (London) - Paediatrics

CTAP centre
NHS Trust
Guy's and St Thomas' NHS Foundation Trust
Address
Royal Brompton Hospital
Sydney Street
SW3 6NP
Recruitment starts
Recruitment ends
Trial Coordinators
Mary Abkir
Recruiting

Royal Manchester Children's Hospital (Paediatrics)

CTAP centre
NHS Trust
Manchester University NHS Foundation Trust
Address
Oxford Road
M13 9WL
Recruitment starts
Recruitment ends
Recruiting

The Great North Children's Hospital - Newcastle

NHS Trust
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Address
Queen Victoria Road
New Victoria Wing
NE1 4LP
Recruitment starts
Recruitment ends