Feasibility study of Barrier Enhancement for Eczema Preventio

Not Applicable

Completed

• Conditions: Prevention of eczema; Skin and Connective Tissue Diseases; Other dermatitis

• Registration Number: ISRCTN84854178
• Lead Sponsor: ottingham University Hospitals NHS Trust (UK)

Brief Summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25282563

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-26
• Study Completion: 2013-02-01
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of families willing to be randomised. This is the most critical component of the success of any future trial.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Proportion of families eligible for the trial<br> 2. Proportion of families accepting the initial invitation to participate<br> 3. Proportion of families who found the interventions acceptable<br> 4. Reported adherence with intervention<br> 5. Proportion of families for whom the blinding of the assessor to the allocation status was not compromised<br> 6. Amount of contamination as a result of increased awareness in the control group<br> 7. Percentage of missing data and early withdrawal rates<br> 8. Incidence of emollient-related adverse events<br> 9. Incidence of eczema at 6 months<br> 10. Age at onset of eczema and the proportion which are transient cases<br> 11. Filaggrin mutation status<br>