Research project
Title: Barrier Enhancement for Eczema Prevention - BEEP
Project timescale: From 01 December, 2014 to 30 November, 2022
(Added to website on: 12 June, 2014 - Date last updated: 07 July, 2014)
Source of funding:
Health Technology Assessment (HTA) Programme (NIHR)
Aims: The primary objective is to determine whether advising parents to apply emollient to their child’s skin for the first year of life in addition to best practice infant skin care advice can prevent 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. Secondary objectives are to determine any difference in the time to onset of eczema, the severity of eczema, the onset of other allergic diseases, safety issues associated with the emollient, cost effectiveness and long term effects of the intervention.
Research designs used:
Randomised controlled trial
Other:
Methods used to collect data:
Questionnaire survey
Observation
Other (please specify):
Research project description: The trial is a pragmatic, randomised, controlled, multi-centre, assessor blind, parallel group trial. A total of 1282 participants will be recruited over a 24 month period with five year follow up and primary outcome assessed at two years. Screening will take place either during pregnancy or soon after delivery during a face-to-face visit with the researcher. Families will be randomised within three weeks of delivery of their baby to one of two groups in a 1:1 ratio:- •Control Group: Parents given best practice infant skin care advice only. •Intervention Group: Parents given best practice infant skin care advice PLUS advice on how to apply emollient at least once a day for a year to their child’s skin.
Stages at which the public were involved:
Planning the research
Designing the research instruments
(eg questionnaires, patient information sheets)
Assisting in finding and designing appropriate
ways of approaching participants
Other: PPI representatives will also sit on the Trial Steering Committee
Description of public involvement in research stages: Guidance was sought from the pilot trial participants for feedback and guidance. This had a direct impact on the type of emollients chosen in the main trial. Before submitting to ethics all questionnaires and information sheets were reviewed by the PPI panel and amended accordingly. We will continue to use the PPI group throughout the duration of the trial, for example TSC meetings.
Training and support provided for either members of the public or researchers involved in the project: Support was provided for the PPI group but no training was required due to the pragmatic nature of the trial. Support included providing an environment in which they could feel comfortable and able to express their thoughts, and providing a contact point - enabling them to contact us at any point if they felt necessary.
Examples of ways the public have made a difference to the research project: Public involvement has impacted on the type of emollient used, the duration of the intervention being appropriate and convenient, the type and length of questions in the questionnaires, review of the letters and information sheets and on the Trial Steering Committee to guide the trial team.
Evaluating the impact of public involvement in the research: No current plans.
Details of publications or reports resulting from the research: The BEEP trial is in the set up stage so currently there have been no reports or articles produced.
Links to Reports:
Was/is your project user controlled: No
For further information on the project, please contact:
Miss Amy Moody
Trial Manager
Nottingham Clinical Trials Unit
Nottingham Health Science Partners
C Floor, South Block
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
beep@nottingham.ac.uk
0115 8844926
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