Condition category
Skin and Connective Tissue Diseases
Date applied
25/07/2014
Date assigned
25/07/2014
Last edited
25/07/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 baby’s 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 don’t 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 Joanne Chalmers
joanne.chalmers@nottingham.ac.uk

Trial website

http://beepstudy.org/

Contact information

Type

Scientific

Primary contact

Dr Joanne Chalmers

ORCID ID

Contact details

Nottingham Clinical Trials Unit
Nottingham Health Science Partners
Room 2201
C Floor
South Block
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 823 2435
joanne.chalmers@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16940; HTA 12/67/12

Study information

Scientific title

A randomised controlled trial to determine whether application of emollient from birth for a year, can prevent eczema in high-risk children

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.

A copy of the trial protocol can be found at: https://www.journalslibrary.nihr.ac.uk/programmes/hta/126712/#/documentation

Ethics approval

14\WM\0162; First MREC approval date 09/06/2014

Study design

Randomised; Interventional; Design type: Prevention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

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 child’s 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 child’s 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 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

Overall trial start date

01/11/2014

Overall trial end date

30/10/2021

Reason abandoned

Eligibility

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 type

Patient

Age group

Neonate

Gender

Both

Target number of participants

Maximum of 1400 children

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

United Kingdom

Trial participating centre

Centre of Evidence-Based Dermatology
University of Nottingham C Floor, South Block Queen’s Medical Centre Nottingham University Hospitals NHS Trust
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

St Mary's Hospital
Dermatology Dept Milton Road
Portsmouth
PO3 6AD
United Kingdom

Trial participating centre

Harrogate District Hospital
Lancaster Park Road
Harrogate
HG2 7SX
United Kingdom

Trial participating centre

Kings Mill Hospital
Mansfield Road
Sutton in Ashfield
NG17 4JL
United Kingdom

Trial participating centre

Queen's Hospital
Burton Hospitals NHS Belvedere Road
Burton upon Trent
DE13 0RB
United Kingdom

Trial participating centre

Derby Children’s Hospital
Royal Derby Hospital Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Trial participating centre

Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Trial participating centre

York Hospital
Wiggington Road
York
YO31 8HE
United Kingdom

Trial participating centre

University of Sheffield
K Floor The Medical School (RHH tower) Beech Hill Road
Sheffield
S10 2RX
United Kingdom

Trial participating centre

St Mary’s Hospital
Imperial College Healthcare NHS Trust
London
W2 1NY
United Kingdom

Trial participating centre

Francis Grove Medical Practice
Wimbledon
London
SW19 4DL
United Kingdom

Trial participating centre

Streatham Common Medical Practice
St Andrew’s Church room Guildersfield Road
London
SW16 5LS
United Kingdom

Trial participating centre

Clapham Park Group Practice
72 Clarence Avenue Clapham Park
London
SW4 8JP
United Kingdom

Trial participating centre

Park Group Practice
Annerley
London
SE20 8AJ
United Kingdom

Trial participating centre

St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Trial participating centre

University of Bristol
Room 1.01a Canynge Hall 39 Whatley Road
Bristol
BS8 2PS
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

IPD sharing statement
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.

Intention to publish date

Participant level data

Other

Results - basic reporting

Publication summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28732519

Publication citations

Additional files

Editorial Notes

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