ISRCTN21528841
Completed
N/A
A randomised controlled trial to determine whether application of emollient from birth for a year, can prevent eczema in high-risk children
niversity of Nottingham (UK)0 sites1,394 target enrollmentJuly 25, 2014
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Topic: Children, Primary Care, Dermatology
- Sponsor
- niversity of Nottingham (UK)
- Enrollment
- 1394
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28732519 protocol 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32087126 results (added 24/02/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32546180/ SWAT results 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36263451/ 5-year results (added 16/11/2022) 2024 Results article in https://doi.org/10.1111/all.16203 Prevalence and risk factors for milk allergy overdiagnosis in the BEEP trial cohort (added 20/06/2024) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39021147/ Emollient application (added 19/07/2024)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria as of 08/12/2016:
- •1\. Child has a first degree relative with parental reported doctor diagnosis of eczema, allergic rhinitis or asthma.
- •2\. Child up to 21 days old.
- •3\. Mothers must be aged \=16 years
- •4\. Consenting adult has the ability to understand English.
- •Original 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
Exclusion Criteria
- •Exclusion criteria as of 08/12/2016:
- •1\. Preterm birth (defined as birth prior to 37 weeks gestation)
- •2\. Sibling (including twin) previously randomised to this trial. If multiple birth the first child will be randomised into the trial
- •3\. Child has a severe widespread skin condition that would make the detection and/or assessment of eczema difficult
- •4\. Child has a serious health issue which, at parent or investigator discretion, would make it difficult for the family to take part in the trial
- •5\. Any condition that would make the use of emollient inadvisable or not possible
- •Original 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
Outcomes
Primary Outcomes
Not specified
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