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Skin emollient and ...
Skin emollient and early complementary feeding to prevent infant atopic dermatitis (PreventADALL): a factorial, multicentre, cluster-randomised trial
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Skjerven, H. O. (författare)
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Rehbinder, E. M. (författare)
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Vettukattil, R. (författare)
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visa fler...
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LeBlanc, M. (författare)
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Granum, B. (författare)
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Haugen, G. (författare)
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- Hedlin, G. (författare)
- Karolinska Institutet
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Landrø, L. (författare)
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Marsland, B. J. (författare)
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Rudi, K. (författare)
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Sjøborg, K. D. (författare)
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- Söderhäll, C. (författare)
- Karolinska Institutet
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- Staff, A. C. (författare)
- Karolinska Institutet
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Carlsen, K. H. (författare)
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- Asarnoj, A. (författare)
- Karolinska Institutet
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Bains, K. E. S. (författare)
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Carlsen, O. C. L. (författare)
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Endre, K. M. A. (författare)
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Granlund, P. A. (författare)
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Hermansen, J. U. (författare)
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Gudmundsdóttir, H. K. (författare)
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Hilde, K. (författare)
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Håland, G. (författare)
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Kreyberg, I. (författare)
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Olsen, I. C. (författare)
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Mägi, C. A. O. (författare)
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Nordhagen, L. S. (författare)
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Saunders, C. M. (författare)
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Skrindo, I. (författare)
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- Tedner, S. G. (författare)
- Karolinska Institutet
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Værnesbranden, M. R. (författare)
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- Wiik, Johanna (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för obstetrik och gynekologi,Institute of Clinical Sciences, Department of Obstetrics and Gynecology
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Jonassen, C. M. (författare)
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- Nordlund, B. (författare)
- Karolinska Institutet
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Carlsen, K. C. L. (författare)
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(creator_code:org_t)
- 2020
- 2020
- Engelska.
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Ingår i: The Lancet. - 0140-6736. ; 395:10228, s. 951-961
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Background: Skin emollients applied during early infancy could prevent atopic dermatitis, and early complementary food introduction might reduce food allergy in high-risk infants. The study aimed to determine if either regular skin emollients applied from 2 weeks of age, or early complementary feeding introduced between 12 and 16 weeks of age, reduced development of atopic dermatitis by age 12 months in the general infant population. Methods: This population-based 2×2 factorial, randomised clinical trial was done at Oslo University Hospital and Østfold Hospital Trust, Oslo, Norway; and Karolinska University Hospital, Stockholm, Sweden. Infants of women recruited antenatally at the routine ultrasound pregnancy screening at 18 weeks were cluster-randomised at birth from 2015 to 2017 to the following groups: (1) controls with no specific advice on skin care while advised to follow national guidelines on infant nutrition (no intervention group); (2) skin emollients (bath additives and facial cream; skin intervention group); (3) early complementary feeding of peanut, cow's milk, wheat, and egg (food intervention group); or (4) combined skin and food interventions (combined intervention group). Participants were randomly assigned (1:1:1:1) using computer- generated cluster randomisation based on 92 geographical living area blocks as well as eight 3-month time blocks. Carers were instructed to apply the interventions on at least 4 days per week. Atopic dermatitis by age 12 months was the primary outcome, based on clinical investigations at 3, 6 and 12 months by investigators masked to group allocation. Atopic dermatitis was assessed after completing the 12-month investigations and diagnosed if either of the UK Working Party and Hanifin and Rajka (12 months only) diagnostic criteria were fulfilled. The primary efficacy analyses was done by intention-to-treat analysis on all randomly assigned participants. Food allergy results will be reported once all investigations at age 3 years are completed in 2020. This was a study performed within ORAACLE (the Oslo Research Group of Asthma and Allergy in Childhood; the Lung and Environment). The study is registered at clinicaltrials.gov, NCT02449850. Findings: 2697 women were recruited between Dec 9, 2014, and Oct 31, 2016, from whom 2397 newborn infants were enrolled from April 14, 2015, to April 11, 2017. Atopic dermatitis was observed in 48 (8%) of 596 infants in the no intervention group, 64 (11%) of 575 in the skin intervention group, 58 (9%) of 642 in the food intervention group, and 31 (5%) of 583 in the combined intervention group. Neither skin emollients nor early complementary feeding reduced development of atopic dermatitis, with a risk difference of 3·1% (95% CI –0·3 to 6·5) for skin intervention and 1·0% (–2·1 to 4·1) for food intervention, in favour of control. No safety concerns with the interventions were identified. Reported skin symptoms and signs (including itching, oedema, exanthema, dry skin, and urticaria) were no more frequent in the skin, food, and combined intervention groups than in the no intervention group. Interpretation: Neither early skin emollients nor early complementary feeding reduced development of atopic dermatitis by age 12 months. Our study does not support the use of these interventions to prevent atopic dermatitis by 12 months of age in infants. Funding: The study was funded by several public and private funding bodies: The Regional Health Board South East, The Norwegian Research Council, Health and Rehabilitation Norway, The Foundation for Healthcare and Allergy Research in Sweden-Vårdalstiftelsen, Swedish Asthma and Allergy Association's Research Foundation, Swedish Research Council—the Initiative for Clinical Therapy Research, The Swedish Heart-Lung Foundation, SFO-V at the Karolinska Institute, Freemason Child House Foundation in Stockholm, Swedish Research Council for Health, Working Life and Welfare—FORTE, Oslo University Hospital, the University of Oslo, and Østfold Hospital Trust. © 2020 Elsevier Ltd
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Dermatologi och venereologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Dermatology and Venereal Diseases (hsv//eng)
Nyckelord
- dermatological agent
- drug additive
- emollient agent
- adult
- Article
- atopic dermatitis
- biogeographic region
- childbirth
- clinical assessment
- clinical effectiveness
- clinical outcome
- cluster analysis
- complementary feeding
- computer analysis
- controlled study
- cow milk
- cream
- diagnostic test
- diet therapy
- disease control
- dry skin
- early childhood intervention
- echography
- egg
- factorial design
- female
- food allergy
- gestational age
- human
- infant
- infant nutrition
- intention to treat analysis
- major clinical study
- male
- multicenter study
- newborn
- Norway
- peanut
- population research
- practice guideline
- prenatal period
- priority journal
- pruritus
- randomized controlled trial
- rash
- skin care
- skin edema
- skin examination
- Sweden
- treatment duration
- university hospital
- urticaria
- wheat
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
Hitta via bibliotek
Till lärosätets databas
- Av författaren/redakt...
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Skjerven, H. O.
-
Rehbinder, E. M.
-
Vettukattil, R.
-
LeBlanc, M.
-
Granum, B.
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Haugen, G.
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visa fler...
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Hedlin, G.
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Landrø, L.
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Marsland, B. J.
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Rudi, K.
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Sjøborg, K. D.
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Söderhäll, C.
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Staff, A. C.
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Carlsen, K. H.
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Asarnoj, A.
-
Bains, K. E. S.
-
Carlsen, O. C. L ...
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Endre, K. M. A.
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Granlund, P. A.
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Hermansen, J. U.
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Gudmundsdóttir, ...
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Hilde, K.
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Håland, G.
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Kreyberg, I.
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Olsen, I. C.
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Mägi, C. A. O.
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Nordhagen, L. S.
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Saunders, C. M.
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Skrindo, I.
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Tedner, S. G.
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Værnesbranden, M ...
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Wiik, Johanna
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Jonassen, C. M.
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Nordlund, B.
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Carlsen, K. C. L ...
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visa färre...
- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Dermatologi och ...
- Artiklar i publikationen
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The Lancet
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Lancet (London, ...
- Av lärosätet
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Göteborgs universitet
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Karolinska Institutet