Feasibility study of Barrier Enhancement for Eczema Prevention

ISRCTN	ISRCTN84854178
DOI	https://doi.org/10.1186/ISRCTN84854178
ClinicalTrials.gov number	NCT01142999
Secondary identifying numbers	UK: 09DE005; USA: 6083

Submission date: 08/01/2010
Registration date: 26/02/2010
Last edited: 04/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Joanne Chalmers
Scientific

Centre of Evidence Based Dermatology
Kings Meadow Campus
University of Nottingham
Lenton Lane
Nottingham
NG7 2NR
United Kingdom

Study information

Study design	Multicentre assessor-blinded randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Prevention
Participant information sheet	Can be found at http://www.beepstudy.org
Scientific title	Feasibility study of Barrier Enhancement for Eczema Prevention: a multicentre, assessor-blinded, randomised controlled trial
Study acronym	The BEEP Study
Study objectives	Enhancing the skin barrier from birth with emollients will prevent or delay the onset of eczema in high risk infants.
Ethics approval(s)	1. UK: Nottingham Research Ethics Committee 1, 13/11/2009, ref: 09/H0407/43 2. USA: OHSU Research Integrity Office
Health condition(s) or problem(s) studied	Prevention of eczema
Intervention	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. As of 21/03/2012, the record has been updated to include the following: The study has been extended to follow up the participants until their 2nd birthday. The 6 month intervention period remains unchanged. 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
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Sunflower seed oil, Doublebase, white soft paraffin, liquid paraffin
Primary outcome measure	Proportion of families willing to be randomised. This is the most critical component of the success of any future trial.
Secondary outcome measures	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
Overall study start date	01/02/2010
Completion date	01/02/2013

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	200 infants to be enrolled
Key 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
Key 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)
Date of first enrolment	01/02/2010
Date of final enrolment	01/02/2013

Locations

Countries of recruitment

England
United Kingdom
United States of America

Study participating centre

Centre of Evidence Based Dermatology

Nottingham
NG7 2NR
United Kingdom

Sponsor information

Nottingham University Hospitals NHS Trust (UK)
Hospital/treatment centre

Research & Development Department
E11, Curie Court
Queens Medical Centre
Nottingham
NG7 2UH
England
United Kingdom

Website	http://www.nuh.nhs.uk/
"ROR"	https://ror.org/05y3qh794

Funders

Funder type

Government

Programme Grants for Applied Research (PGfAR) (ref: RP-PG-0407-1017)
Government organisation / National government

Alternative name(s): NIHR Programme Grants for Applied Research, PGfAR
Location: United Kingdom

National Eczema Association (USA) (added 13/07/2010)
Government organisation / Associations and societies (private and public)

Alternative name(s): National Eczema Assoc., NEA
Location: United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2014		Yes	No

Editorial Notes

04/01/2019: Internal review.

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

As of 21/03/2012, the anticipated end date of trial has been updated from 04/07/2011 to 01/02/2013.