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11 February 2012
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| [ Print-friendly version ] |
| Feasibility study of Barrier Enhancement for Eczema Prevention |
| ISRCTN | ISRCTN84854178 |
| ClinicalTrials.gov identifier | NCT01142999 |
| Public title | Feasibility study of Barrier Enhancement for Eczema Prevention |
| Scientific title | Feasibility study of Barrier Enhancement for Eczema Prevention: a multicentre, assessor-blinded, randomised controlled trial |
| Acronym | The BEEP Study |
| Serial number at source | UK: 09DE005; USA: 6083 |
| Study hypothesis |
Enhancing the skin barrier from birth with emollients will prevent or delay the onset of eczema in high risk infants.
Please note that as of 13/07/2010 this record was updated to include more information on the USA study site and a few protocol amendments to the UK site information. All additions can be found in the relevant section with the subtitle: ‘USA site’, or with the above update date. At this time, the target number of participants for the study was amended to read 200 patients to be enrolled in total (previously 50). This takes into account how many it is anticipated will be needed to be enrolled in each country (100) to reach a randomised number of 50 in each country. Please also note that the study dates for each site are as follows: UK anticipated trial dates: Start date: 01/02/2010 End date: 01/02/2011 USA anticipated trial dates: Start date: 04/08/2010 End date: 04/07/2011 |
| Lay summary | |
| Ethics approval |
1. UK: Nottingham Research Ethics Committee 1 approved on the 13th November 2009 (ref: 09/H0407/43)
2. USA: OHSU Research Integrity Office |
| Study design | Multicentre assessor-blinded randomised controlled trial |
| Countries of recruitment | United Kingdom, United States of America |
| Disease/condition/study domain | Prevention of eczema |
| Participants - inclusion criteria |
UK and USA:
1. Infants with a family history of eczema, asthma or allergic rhinitis 2. Infant in overall good health 3. Mother aged between 16 and 45 years at delivery and capable of giving informed consent |
| Participants - exclusion criteria |
UK and USA:
1. Preterm birth (defined as birth prior to 37 weeks gestation) 2. Major congenital anomaly 3. Hydrops fetalis 4. Significant dermatitis at birth not including seborrheic dermatitis (“cradle cap”) (added 13/07/2010) 5. Any severe genetic skin disorder or immunodeficiency 6. Any other serious condition that would make the use of emollients inadvisable 7. Any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention or in whom assessing the outcomes may be masked by the underlying problem or practically very difficult to assess 8. Taken supplements containing Lactobacillus Rhamnosus during pregnancy or plan to take whilst lactating (added 13/07/2010) |
| Anticipated start date | 01/02/2010 |
| Anticipated end date | 04/07/2011 |
| Status of trial | Completed |
| Patient information material | Can be found at http://www.beepstudy.org |
| Target number of participants | 200 infants to be enrolled |
| Interventions |
UK site:
The intervention group will apply emollient to the infants entire skin surface once a day (except the scalp which is optional) especially after bathing. Parents will choose from three emollients that vary in texture and viscosity: 1. Sunflower seed oil 2. Doublebase 3. 50:50 white soft paraffin/liquid paraffin The control group will not apply emollients USA site: The intervention group will apply emollient to the infants entire skin surface once a day (except the scalp which is optional) especially after bathing. Parents will choose from three emollients that vary in texture and viscosity: 1. Sunflower oil 2. Cetaphil cream 3. Aquaphor ointment The control group will not apply emollients Both sites: The intervention will commence within 3 weeks of the birth. Both the intervention and control groups will receive best practice instructions on bathing and cleansing of their infant which will be standardised to minimise investigator counselling and inter-investigator variability: 1. Avoid the use of soap and bubble bath 2. Use only a mild cleanser and shampoo 3. The use of baby wipes will be discouraged Total duration of treatment and follow up is 6 months for all arms. Sponsor details for the USA site: National Eczema Association (USA) 4460 Redwood Highway, Suite 16-D San Rafael, California 94903-1953 United States of America Website: http://www.nationaleczema.org Contact details for the USA site : Dr Eric Simpson Oregon Health & Science University Department of Dermatology (CH16D) 3303 S.W. Bond Avenue Portland, Oregon 97239-4501 United States of America |
| Primary outcome measure(s) | Proportion of families willing to be randomised. This is the most critical component of the success of any future trial. |
| Secondary outcome measure(s) |
1. Proportion of families eligible for the trial
2. Proportion of families accepting the initial invitation to participate 3. Proportion of families who found the interventions acceptable 4. Reported adherence with intervention 5. Proportion of families for whom the blinding of the assessor to the allocation status was not compromised 6. Amount of contamination as a result of increased awareness in the control group 7. Percentage of missing data and early withdrawal rates 8. Incidence of emollient-related adverse events 9. Incidence of eczema at 6 months 10. Age at onset of eczema and the proportion which are transient cases 11. Filaggrin mutation status |
| Sources of funding |
1. National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0407-1017)
2. National Eczema Association (USA) (added 13/07/2010) |
| Trial website | http://www.beepstudy.org |
| Publications | |
| Contact name | Dr Joanne Chalmers |
| Address |
Centre of Evidence Based Dermatology
Kings Meadow Campus University of Nottingham Lenton Lane |
| City/town | Nottingham |
| Zip/Postcode | NG7 2NR |
| Country | United Kingdom |
| Sponsor | Nottingham University Hospitals NHS Trust (UK) |
| Address |
Research & Development Department
E11, Curie Court Queen’s Medical Centre |
| City/town | Nottingham |
| Zip/Postcode | NG7 2UH |
| Country | United Kingdom |
| Sponsor website: | http://www.nuh.nhs.uk/ |
| Date applied | 08/01/2010 |
| Last edited | 13/07/2010 |
| Date ISRCTN assigned | 26/02/2010 |
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