Clinical trial NCT04680520: Barrier Enhancement for Eczema Prevention
Official title: A Randomised Controlled Trial to Determine Whether Application of Emollient From Birth Can Prevent Eczema in High Risk Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eczema
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2020-12-23
Enrollment: 1394
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective is to determine whether advising parents to apply emollient (moisturiser) to their child's skin for the first year of life in addition to best practice infant skin care advice can prevent or delay the onset of eczema in high-risk children, when compared with a control group who are given the best practice infant skin care advice only.


Eligibility criteria: Inclusion Criteria:

* child has a first degree relative with parental reported doctor diagnosis of eczema, allergic rhinitis or asthma
* child up to 21 days old
* consenting adult has the ability to understand English

Exclusion Criteria:

* preterm birth (defined as birth prior to 37 weeks gestation)
* sibling (including twin) previously randomized to this trial. If multiple births, the first child will be randomized into the trial.
* child has a severe widespread skin condition that would make the detection and/or assessment or eczema difficult
* child has a serious health issue, which, at parent or investigator discretion, would make it difficult for the family to take part in the trial
* any condition that would make the use of emollient inadvisable or not possible

Primary outcomes:
measure: A diagnosis of eczema between 12 and 24 months of age (defined as meeting the United Kingdom (UK) Working Party Diagnostic Criteria for Atopic Dermatitis).
timeFrame: 24 months
Secondary outcomes:
measure: Presence of parental report of eczema between birth and 24 months.
timeFrame: Up to 24 months
measure: Presence of visible eczema at 24 months (skin examination by researcher).
timeFrame: 24 months
measure: Time to onset of eczema
timeFrame: 24 months
measure: Presence of other allergic diseases using parental reports, allergic sensitization and confirmed diagnosis
timeFrame: Upto 24 months
measure: Child health-related quality adjusted life years.
timeFrame: Upto 24 months
measure: Parental health-related quality adjusted life years.
timeFrame: Upto 24 months
measure: Cost or treatments- health economic outcomes
timeFrame: Up to 24 months
measure: Severity of eczema with EASI eczema severity scales
timeFrame: Up to 24 months
measure: Severity of eczema with POEM eczema severity scales
timeFrame: Up to 24 months
Other outcomes:
measure: Presence of eczema in the previous year at 36, 48 and 60 months based on parental report of a clinical diagnosis of eczema
timeFrame: 36, 48 and 60 months
measure: Any parental report that in their opinion their child has eczema at 3, 6, 12, 24, 36, 48 and 60 months
timeFrame: 3, 6, 12, 24, 36, 48 and 60 months
measure: Presence of eczema at 36, 48 and 60 months based on completion by parents of UK Working Party Diagnostic Criteria for Atopic Dermatitis
timeFrame: 36, 48 and 60 months
measure: Severity of eczema at 36, 48, and 60 months as measured by POEM
timeFrame: 36, 48, and 60 months
measure: Parental reported wheezing, at 36, 48 and 60 months
timeFrame: 36, 48 and 60 months
measure: Parental reported allergic rhinitis at 36, 48 and 60 months
timeFrame: 36, 48 and 60 months
measure: Parental reported food allergy symptoms at 36, 48 and 60 months
timeFrame: 36, 48 and 60 months
measure: Parental report of a clinical diagnosis of asthma or allergic rhinitis by 60 months
timeFrame: By 60 months
measure: Parental report of a clinical diagnosis of food allergy at 36, 48 and 60 months
timeFrame: 36, 48 and 60 months
measure: CHU-9D at 36, 48 and 60 months in order to estimate QALYs
timeFrame: 36, 48 and 60 months
measure: Parental quality of life measured using EQ-5D-5L at 36, 48 and 60 months in order to estimate parental QALYs
timeFrame: 36, 48 and 60 months
measure: Health care resource use at 36, 48 and 60 months
timeFrame: 36, 48 and 60 months
measure: Cost utility and cost-effectiveness at 60 months (combining health resource use and health-related quality of life outcomes)
timeFrame: 60 months
measure: Parental report of clinical diagnosis of eczema from the age of 12 months to 60 months
timeFrame: 12 months to 60 months
measure: Parental report of clinical diagnosis of food allergy by 60 months
timeFrame: By 60 months
Locations:
city: Bristol
country: United Kingdom
facility: School of Social and Community Medicine, University of Bristol
city: Burton
country: United Kingdom
facility: Queens Hospital
city: Derby
country: United Kingdom
facility: Derby Childrens Hosptia
city: Harrogate
country: United Kingdom
facility: Harrogate District Hospital
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Clapham Park Group Practice
city: London
country: United Kingdom
facility: Francis Grove Medical Practice
city: London
country: United Kingdom
facility: Park Group Practice
city: London
country: United Kingdom
facility: St John's Institute of Dermatology
city: London
country: United Kingdom
facility: St Mary's Hospital
city: London
country: United Kingdom
facility: Streatham Common Medical Practice
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Portsmouth
country: United Kingdom
facility: St Mary's Hospital
city: Sheffield
country: United Kingdom
facility: Academic Unit of Dermatology Research, Univeristy of Sheffield
city: Sutton in Ashfield
country: United Kingdom
facility: Kings Mill Hospital
city: York
country: United Kingdom
facility: York Hospital
Study officials:
affiliation: Centre of Evidence-Based Dermatology, University of Nottingham.
name: Hywel Williams
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bradshaw LE, Wyatt LA, Brown SJ, Haines RH, Montgomery AA, Perkin MR, Lawton S, Sach TH, Chalmers JR, Ridd MJ, Flohr C, Brooks J, Swinden R, Mitchell EJ, Tarr S, Jay N, Thomas KS, Allen H, Cork MJ, Kelleher MM, Simpson EL, Lartey ST, Davies-Jones S, Boyle RJ, Williams HC. Emollients for prevention of atopic dermatitis: 5-year findings from the BEEP randomized trial. Allergy. 2023 Apr;78(4):995-1006. doi: 10.1111/all.15555. Epub 2022 Nov 3.
citation: Chalmers JR, Haines RH, Bradshaw LE, Montgomery AA, Thomas KS, Brown SJ, Ridd MJ, Lawton S, Simpson EL, Cork MJ, Sach TH, Flohr C, Mitchell EJ, Swinden R, Tarr S, Davies-Jones S, Jay N, Kelleher MM, Perkin MR, Boyle RJ, Williams HC; BEEP study team. Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial. Lancet. 2020 Mar 21;395(10228):962-972. doi: 10.1016/S0140-6736(19)32984-8. Epub 2020 Feb 19.
citation: Bradshaw LE, Montgomery AA, Williams HC, Chalmers JR, Haines RH. Two-by-two factorial randomised study within a trial (SWAT) to evaluate strategies for follow-up in a randomised prevention trial. Trials. 2020 Jun 8;21(1):529. doi: 10.1186/s13063-020-04373-4.