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Clinical Trials/ISRCTN21528841
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)

Registry
who.int
Start Date
July 25, 2014
End Date
October 30, 2021
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Nottingham (UK)

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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