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Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial

Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial
Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial

BACKGROUND: Skin barrier dysfunction precedes eczema development. We tested whether daily use of emollient in the first year could prevent eczema in high-risk children.

METHODS: We did a multicentre, pragmatic, parallel-group, randomised controlled trial in 12 hospitals and four primary care sites across the UK. Families were approached via antenatal or postnatal services for recruitment of term infants (at least 37 weeks' gestation) at high risk of developing eczema (ie, at least one first-degree relative with parent-reported eczema, allergic rhinitis, or asthma, diagnosed by a doctor). Term newborns with a family history of atopic disease were randomly assigned (1:1) to application of emollient daily (either Diprobase cream or DoubleBase gel) for the first year plus standard skin-care advice (emollient group) or standard skin-care advice only (control group). The randomisation schedule was created using computer-generated code (stratified by recruiting centre and number of first-degree relatives with atopic disease) and participants were assigned to groups using an internet-based randomisation system. The primary outcome was eczema at age 2 years (defined by UK working party criteria) with analysis as randomised regardless of adherence to allocation for participants with outcome data collected, and adjusting for stratification variables. This trial is registered with ISRCTN, ISRCTN21528841. Data collection for long-term follow-up is ongoing, but the trial is closed to recruitment.

FINDINGS: 1394 newborns were randomly assigned to study groups between Nov 19, 2014, and Nov 18, 2016; 693 were assigned to the emollient group and 701 to the control group. Adherence in the emollient group was 88% (466 of 532) at 3 months, 82% (427 of 519) at 6 months, and 74% (375 of 506) at 12 months in those with complete questionnaire data. At age 2 years, eczema was present in 139 (23%) of 598 infants with outcome data collected in the emollient group and 150 (25%) of 612 infants in the control group (adjusted relative risk 0·95 [95% CI 0·78 to 1·16], p=0·61; adjusted risk difference -1·2% [-5·9 to 3·6]). Other eczema definitions supported the results of the primary analysis. Mean number of skin infections per child in year 1 was 0·23 (SD 0·68) in the emollient group versus 0·15 (0·46) in the control group; adjusted incidence rate ratio 1·55 (95% CI 1·15 to 2·09).

INTERPRETATION: We found no evidence that daily emollient during the first year of life prevents eczema in high-risk children and some evidence to suggest an increased risk of skin infections. Our study shows that families with eczema, asthma, or allergic rhinitis should not use daily emollients to try and prevent eczema in their newborn.

FUNDING: National Institute for Health Research Health Technology Assessment.

Dermatitis, Atopic/drug therapy, Dose-Response Relationship, Drug, Drug Administration Schedule, Eczema/drug therapy, Emollients/therapeutic use, Female, Follow-Up Studies, Humans, Infant, Infant, Newborn, Male, Reference Values, Risk Assessment, Treatment Outcome, United Kingdom
0140-6736
962-972
Chalmers, Joanne R
94e08e98-5c93-405d-9278-97acfe4985a0
Haines, Rachel H
efd463e9-1a86-4370-8a76-21e3065f8350
Bradshaw, Lucy E
4efb4747-f146-4816-b06e-982bf895c6a3
Montgomery, Alan A
6f6e4e9e-e78b-43b0-9334-05522cfd6cdf
Thomas, Kim S
75e143ff-868e-47dc-b892-c9745a7e496a
Brown, Sara J
4c6024a6-25f4-4e18-808e-d8263aea02fe
Ridd, Matthew J
de8b7ad0-5afa-4231-99f6-d6778744ddd4
Lawton, Sandra
610566de-d907-4721-ac53-6ef72f9e708d
Simpson, Eric L
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Cork, Michael J
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Sach, Tracey H
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Flohr, Carsten
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Mitchell, Eleanor J
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Swinden, Richard
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Tarr, Stella
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Davies-Jones, Susan
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Jay, Nicola
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Kelleher, Maeve M
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Perkin, Michael R
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Boyle, Robert J
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Williams, Hywel C
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BEEP study team
Chalmers, Joanne R
94e08e98-5c93-405d-9278-97acfe4985a0
Haines, Rachel H
efd463e9-1a86-4370-8a76-21e3065f8350
Bradshaw, Lucy E
4efb4747-f146-4816-b06e-982bf895c6a3
Montgomery, Alan A
6f6e4e9e-e78b-43b0-9334-05522cfd6cdf
Thomas, Kim S
75e143ff-868e-47dc-b892-c9745a7e496a
Brown, Sara J
4c6024a6-25f4-4e18-808e-d8263aea02fe
Ridd, Matthew J
de8b7ad0-5afa-4231-99f6-d6778744ddd4
Lawton, Sandra
610566de-d907-4721-ac53-6ef72f9e708d
Simpson, Eric L
2ecb9d6f-70ee-4641-bb84-e16b62d5dd37
Cork, Michael J
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Sach, Tracey H
5c09256f-ebed-4d14-853a-181f6c92d6f2
Flohr, Carsten
3f23e285-22a5-4c8a-9848-e98dab555531
Mitchell, Eleanor J
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Swinden, Richard
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Tarr, Stella
185e3183-b8d7-4dd2-b6f5-4ec341fa87be
Davies-Jones, Susan
0e83bb9f-c9d8-490c-9085-c51a1646d5ad
Jay, Nicola
6cfece3b-b0e5-43ba-8cdb-8da8d4cb8180
Kelleher, Maeve M
9e3dcc86-7cb8-4b3f-a363-a2563fe173ae
Perkin, Michael R
8af1930f-5d70-4322-a75b-ad23e1f1c106
Boyle, Robert J
cce30158-f576-4cd3-a790-421decaccec5
Williams, Hywel C
3914e691-2348-4704-a044-e8d2af92444e

BEEP study team (2020) Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial. The Lancet, 395 (10228), 962-972. (doi:10.1016/S0140-6736(19)32984-8).

Record type: Article

Abstract

BACKGROUND: Skin barrier dysfunction precedes eczema development. We tested whether daily use of emollient in the first year could prevent eczema in high-risk children.

METHODS: We did a multicentre, pragmatic, parallel-group, randomised controlled trial in 12 hospitals and four primary care sites across the UK. Families were approached via antenatal or postnatal services for recruitment of term infants (at least 37 weeks' gestation) at high risk of developing eczema (ie, at least one first-degree relative with parent-reported eczema, allergic rhinitis, or asthma, diagnosed by a doctor). Term newborns with a family history of atopic disease were randomly assigned (1:1) to application of emollient daily (either Diprobase cream or DoubleBase gel) for the first year plus standard skin-care advice (emollient group) or standard skin-care advice only (control group). The randomisation schedule was created using computer-generated code (stratified by recruiting centre and number of first-degree relatives with atopic disease) and participants were assigned to groups using an internet-based randomisation system. The primary outcome was eczema at age 2 years (defined by UK working party criteria) with analysis as randomised regardless of adherence to allocation for participants with outcome data collected, and adjusting for stratification variables. This trial is registered with ISRCTN, ISRCTN21528841. Data collection for long-term follow-up is ongoing, but the trial is closed to recruitment.

FINDINGS: 1394 newborns were randomly assigned to study groups between Nov 19, 2014, and Nov 18, 2016; 693 were assigned to the emollient group and 701 to the control group. Adherence in the emollient group was 88% (466 of 532) at 3 months, 82% (427 of 519) at 6 months, and 74% (375 of 506) at 12 months in those with complete questionnaire data. At age 2 years, eczema was present in 139 (23%) of 598 infants with outcome data collected in the emollient group and 150 (25%) of 612 infants in the control group (adjusted relative risk 0·95 [95% CI 0·78 to 1·16], p=0·61; adjusted risk difference -1·2% [-5·9 to 3·6]). Other eczema definitions supported the results of the primary analysis. Mean number of skin infections per child in year 1 was 0·23 (SD 0·68) in the emollient group versus 0·15 (0·46) in the control group; adjusted incidence rate ratio 1·55 (95% CI 1·15 to 2·09).

INTERPRETATION: We found no evidence that daily emollient during the first year of life prevents eczema in high-risk children and some evidence to suggest an increased risk of skin infections. Our study shows that families with eczema, asthma, or allergic rhinitis should not use daily emollients to try and prevent eczema in their newborn.

FUNDING: National Institute for Health Research Health Technology Assessment.

This record has no associated files available for download.

More information

Published date: 21 March 2020
Additional Information: Copyright © 2020 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.
Keywords: Dermatitis, Atopic/drug therapy, Dose-Response Relationship, Drug, Drug Administration Schedule, Eczema/drug therapy, Emollients/therapeutic use, Female, Follow-Up Studies, Humans, Infant, Infant, Newborn, Male, Reference Values, Risk Assessment, Treatment Outcome, United Kingdom

Identifiers

Local EPrints ID: 480882
URI: http://eprints.soton.ac.uk/id/eprint/480882
ISSN: 0140-6736
PURE UUID: 2ecf8df7-0375-4f24-9561-71f295aca423
ORCID for Tracey H Sach: ORCID iD orcid.org/0000-0002-8098-9220

Catalogue record

Date deposited: 10 Aug 2023 16:41
Last modified: 14 Jun 2024 02:08

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Contributors

Author: Joanne R Chalmers
Author: Rachel H Haines
Author: Lucy E Bradshaw
Author: Alan A Montgomery
Author: Kim S Thomas
Author: Sara J Brown
Author: Matthew J Ridd
Author: Sandra Lawton
Author: Eric L Simpson
Author: Michael J Cork
Author: Tracey H Sach ORCID iD
Author: Carsten Flohr
Author: Eleanor J Mitchell
Author: Richard Swinden
Author: Stella Tarr
Author: Susan Davies-Jones
Author: Nicola Jay
Author: Maeve M Kelleher
Author: Michael R Perkin
Author: Robert J Boyle
Author: Hywel C Williams
Corporate Author: BEEP study team

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