Condition category
Skin and Connective Tissue Diseases
Date applied
25/07/2014
Date assigned
25/07/2014
Last edited
04/01/2016
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?
Several hospitals around the UK are involved in this study. Hospitals in Nottingham, Imperial College London, Sheffield and Derby are all taking part.

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?
Miss Amy Moody
amy.moody@nottingham.ac.uk

Trial website

http://beepstudy.org/

Contact information

Type

Scientific

Primary contact

Ms Sandip Stapleton

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
-
beep@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16940

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.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=16940 and http://www.nets.nihr.ac.uk/projects/hta/126712
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0012/157989/PRO-12-67-12.pdf

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 below 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

Parent reported - UK Working Party Diagnosic Criteria for atopic deramtitis; Timepoint(s): 12 & 24 months

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

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

Planned Sample Size: 1282; UK Sample Size: 1282; Description: SS assumes 20% attrition.

Participant 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

NIHR Health Technology Assessment Programme - HTA (UK); Grant Codes: HTA 12/67/12

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date
The participant-level data will be freely available but we are still working on our in house policy as to how this information will be available

Intention to publish date

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes