Barrier Enhancement for Eczema Prevention
| ISRCTN | ISRCTN21528841 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21528841 |
| IRAS number | 149888 |
| Secondary identifying numbers | 16940; HTA 12/67/12 |
- Submission date
- 25/07/2014
- Registration date
- 25/07/2014
- Last edited
- 19/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
Children born into families with a history of eczema, asthma or hay fever are more likely to develop eczema. We want to find out if applying moisturisers every day for the first year of life will make a difference to whether children will develop eczema or not.
Who can participate?
Babies who are less than 3 weeks old and who have a direct relative diagnosed with eczema, allergic rhinitis or asthma.
What does the study involve?
If you decide to take part, you will be randomly allocated to either best practice skin care routine for your baby or best practice skin care routine including applying moisturiser to your baby at least once a day for a year. The moisturiser will be provided free of charge. You will be asked to complete some short questionnaires which will be sent and returned either online or by post and you will see a researcher just after your babys second birthday to assess whether they have developed eczema.
What are the possible benefits and risks of participating?
There is very little risk involved in taking part and we dont expect to discover any new side-effects of the skin care advice. Taking part in this study will take up some of your time as you will need to follow the skin care advice until your baby is 1 year old and complete the questionnaires every 3, 6 or 12 months until your child is 5 years old. For those receiving the advice to also apply the moisturiser for a year, there is a low risk that this could cause skin infections because it may block the pores in the skin.
Where is the study run from?
16 sites around the England are involved in running the study, it is being co-ordinated from the Nottingham Clinical Trials Unit in collaboration with the Centre of Evidence Based Dermatology.
When is the study starting and how long is it expected to run for?
November 2014 to October 2021
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Laura Wyatt
beep@nottingham.ac.uk
Contact information
Scientific
Nottingham Clinical Trials Unit
Applied Health Research Building
School of Medicine
University of Nottingham
University Park
Nottingham
NG7 2RD
United Kingdom
| Phone | +44 (0)115 823 2435 |
|---|---|
| beep@nottingham.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Prevention |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomised controlled trial to determine whether application of emollient from birth for a year, can prevent eczema in high-risk children |
| Study acronym | BEEP |
| Study hypothesis | The purpose of the trial is to determine whether advising parents to apply emollient to their child for the first year of life in addition to best practice infant skin care advice can prevent or delay the onset of eczema. Updated 04/01/2019: A copy of the trial protocol, statistical analysis plan and health economics analysis plan can be found at: https://www.journalslibrary.nihr.ac.uk/programmes/hta/126712/#/documentation |
| Ethics approval(s) | 14\WM\0162; First MREC approval date 09/06/2014 |
| Condition | Topic: Children, Primary Care, Dermatology; Subtopic: All Diagnoses, Not Assigned, Skin (all Subtopics); Disease: Dermatology, All Diseases, All Diseases |
| Intervention | Participants are randomised to the intervention group will, in addition, be advised to apply emollient daily to the childs entire body surface area for the first year of life. Parents of children in the intervention group will be given a choice of two emollients (Doublebase Gel® and Diprobase Cream®) and may change between the two emollients throughout the trial if they wish. Families will be seen at around the time of the childs second birthday to collect the primary outcome data, and then followed up for a further 3 years after this. During this time, we will ask parents to complete nine questionnaires at the start the study and then at 3, 6, 12, 18, 24, 36, 48 and 60 months. The questionnaires will include questions about any skin problems, eczema, wheezing, hayfever-like or food allergy symptoms or diagnosis, visits to the doctors and prescriptions, use of skin and wash products, feeding and your quality of life. |
| Intervention type | Other |
| Primary outcome measure | Primary outcome measure as of 08/12/2016: Diagnosis of eczema between 12 and 24 months of age defined as meeting the UK Working Party Diagnostic criteria). Original primary outcome measure: Parent reported - UK Working Party Diagnosic Criteria for atopic deramtitis; Timepoint(s): 12 & 24 months |
| Secondary outcome measures | Secondary outcome measures as of 08/12/2016: 1. Presence of eczema between birth and 24 months is assessed using: 1.1. Any parental report of a clinical diagnosis of eczema 1.2. Completion by parents of UK Working Party Diagnostic Criteria for Atopic Dermatitis at 12 and 24 months 2. Presence of visible eczema at 24 months (skin examination by researcher) 3. Time to onset of eczema is assessed using: 3.1. First parental report of a clinical diagnosis of eczema 3.2. First topical corticosteroid and /or immunosuppressant prescription for eczema 4. Severity of eczema is assessed using EASI at 24 months and POEM*at 12 and 24 months 5. Presence of other allergic diseases: 5.1. Parental reported wheezing and allergic rhinitis between 12 and 24 months 5.2. Parental report of a clinical diagnosis of food allergy at 12 and 24 months 5.3. Parental report of food allergy at 12 and 24 months. Parents will be specifically questioned about cow’s milk, egg, peanuts, and other nuts plus “any other food”. 5.4. Allergic sensitisation at 24 months to any of the following common allergens: milk, egg, peanut, cat, grass pollen, house dust mite. 5.5. Confirmed diagnosis of food allergy at 24 months to milk, egg, peanut or ‘any of milk, egg or peanut’. The diagnosis is derived from a combination of parental report, allergic sensitisation and food challenge. 6. Health-related quality of life is measured using CHU-9D at 24 months in order to estimate QALYs and parental quality of life measured using the EQ-5D-5L at baseline and 24 months in order to estimate the change in parental QALYs, if any 7. Health economic outcomes: 7.1. Health care resource use at 3, 6, 12, 18 and 24 months. 7.2. Cost-effectiveness and cost-utility at 24 months (combining health resource use and health-related quality of life outcomes). Original secondary outcome measures: 1. EASI - Eczema Area and Severity Index; Timepoint(s): 24 months 2. EQ5D-5L - Parental quality of life; Timepoint(s): Baseline and 24 months 3. IDQoL - Infant Dermatitis Quality of Life; Timepoint(s): 24 months 4. POEM - Patient-oriented eczema measure; Timepoint(s): 12 and 24 months Added 01/02/2022: Tertiary outcome measures* 1. Presence of eczema in the previous year at 36, 48 and 60 months based on parental report of a clinical diagnosis of eczema 2. Any parental report that in their opinion their child has eczema at 3, 6, 12, 24, 36, 48 and 60 months 3. Presence of eczema at 36, 48 and 60 months based on completion by parents of UK Working Party Diagnostic Criteria for Atopic Dermatitis 4. Severity of eczema at 36, 48, and 60 months as measured by POEM 5. Parental reported wheezing, at 36, 48 and 60 months 6. Parental reported allergic rhinitis at 36, 48 and 60 months 7. Parental reported food allergy symptoms at 36, 48 and 60 months 8. Parental report of a clinical diagnosis of asthma or allergic rhinitis by 60 months 9. Parental report of a clinical diagnosis of food allergy at 36, 48 and 60 months 10. CHU-9D at 36, 48 and 60 months in order to estimate QALYs 11. Parental quality of life measured using EQ-5D-5L at 36, 48 and 60 months in order to estimate parental QALYs 12. Health care resource use at 36, 48 and 60 months 13. Cost utility and cost-effectiveness at 60 months (combining health resource use and health-related quality of life outcomes) 14. Parental report of clinical diagnosis of eczema from the age of 12 months to 60 months 15. Parental report of clinical diagnosis of food allergy by 60 months *Details of the analyses of the tertiary outcomes were added by the trial statistician after the analysis of the primary and secondary outcomes at which point, the investigators, trial management, data management and statisticians were aware of the results. |
| Overall study start date | 01/11/2014 |
| Overall study end date | 30/10/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | Maximum of 1400 children |
| Total final enrolment | 1394 |
| Participant inclusion criteria | Inclusion criteria as of 08/12/2016: 1. Child has a first degree relative with parental reported doctor diagnosis of eczema, allergic rhinitis or asthma. 2. Child up to 21 days old. 3. Mothers must be aged ≥16 years 4. Consenting adult has the ability to understand English. Original inclusion criteria: 1. Child has a first-degree relative with parental reported doctor diagnosis of eczema, allergic rhinitis or asthma 2. Child in overall good health 3. Child up to three weeks old 4. Consenting adult has the ability to understand English |
| Participant exclusion criteria | Exclusion criteria as of 08/12/2016: 1. Preterm birth (defined as birth prior to 37 weeks gestation) 2. Sibling (including twin) previously randomised to this trial. If multiple birth the first child will be randomised into the trial 3. Child has a severe widespread skin condition that would make the detection and/or assessment of eczema difficult 4. 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 5. Any condition that would make the use of emollient inadvisable or not possible Original exclusion criteria: 1. Preterm birth (defined as birth prior to 37 weeks gestation) 2. Sibling (including twin) previously randomised to this trial 3. Child has serious health issues or a severe widespread skin condition 4. Any condition that would make the use of emollient inadvisable or not possible |
| Recruitment start date | 01/11/2014 |
| Recruitment end date | 30/11/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
C Floor, South Block
Queen’s Medical Centre
Nottingham University Hospitals NHS Trust
Nottingham
NG7 2UH
United Kingdom
Milton Road
Portsmouth
PO3 6AD
United Kingdom
Harrogate
HG2 7SX
United Kingdom
Sutton in Ashfield
NG17 4JL
United Kingdom
Belvedere Road
Burton upon Trent
DE13 0RB
United Kingdom
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Leicester
LE1 5WW
United Kingdom
York
YO31 8HE
United Kingdom
The Medical School (RHH tower)
Beech Hill Road
Sheffield
S10 2RX
United Kingdom
London
W2 1NY
United Kingdom
London
SW19 4DL
United Kingdom
Guildersfield Road
London
SW16 5LS
United Kingdom
Clapham Park
London
SW4 8JP
United Kingdom
London
SE20 8AJ
United Kingdom
London
SE1 7EH
United Kingdom
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
Sponsor information
University/education
Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom
"ROR" |
https://ror.org/01ee9ar58 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan | The participant-level data will be freely available but the trialists are still working on their in-house policy as to how this information will be available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 21/07/2017 | Yes | No | |
| Results article | results | 21/03/2020 | 24/02/2020 | Yes | No |
| Results article | SWAT results | 08/06/2020 | Yes | No | |
| Statistical Analysis Plan | version 2.0 | 06/01/2022 | 17/06/2022 | No | No |
| Protocol file | version 7.0 | 26/02/2021 | 16/11/2022 | No | No |
| Results article | 5-year results | 19/10/2022 | 16/11/2022 | Yes | No |
| Results article | Prevalence and risk factors for milk allergy overdiagnosis in the BEEP trial cohort | 20/06/2024 | 20/06/2024 | Yes | No |
| Results article | Emollient application | 18/07/2024 | 19/07/2024 | Yes | No |
Additional files
Editorial Notes
19/07/2024: Publication reference added.
20/06/2024: Publication reference added.
16/11/2022: The following changes have been made:
1. Publication reference added.
2. A protocol file has been uploaded.
3. The IRAS number has been added.
17/06/2022: The statistical analysis plan (SAP) has been added.
01/02/2022: The contact details and secondary outcome measures were updated.
18/06/2020: Publication reference added.
24/02/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
04/01/2019: Study hypothesis field updated.
25/07/2017: Publication reference added.
08/12/2016: The following changes have been made to the study record:
1. A link to the study protocol has been added to the hypothesis section
2. The outcome measures, inclusion criteria and exclusion criteria have been updated
3. The target number of participants has been updated from 1282 to 1400
4. The study contact has been updated from Sandip Stapleton to Joanne Chalmers
