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Skin emollient and early complementary feeding to prevent infant atopic dermatitis (PreventADALL): a factorial, multicentre, cluster-randomised trial.
Skjerven, HO, Rehbinder, EM, Vettukattil, R, LeBlanc, M, Granum, B, Haugen, G, Hedlin, G, Landrø, L, Marsland, BJ, Rudi, K, et al
Lancet (London, England). 2020;(10228):951-961
Abstract
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.
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Impact of Allergic Reactions on Food-Specific IgE Concentrations and Skin Test Results.
Sicherer, SH, Wood, RA, Vickery, BP, Perry, TT, Jones, SM, Leung, DY, Blackwell, B, Dawson, P, Burks, AW, Lindblad, R, et al
The journal of allergy and clinical immunology. In practice. 2016;(2):239-45.e4
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Abstract
BACKGROUND Although there is concern that food allergy reactions may negatively affect the natural history of food allergy, the impact of reactions on food-specific IgE (sIgE) levels or skin prick test (SPT) wheal size is unknown. OBJECTIVE To measure the effects of allergic reactions on SPT wheal size and sIgE concentrations to milk, egg, and peanut. METHODS Participants included 512 infants with likely milk or egg allergy enrolled in a multicenter observational study. Changes in sIgE level and SPT wheal size to milk, egg, and peanut were measured before and after oral food challenge (OFC) or accidental exposure for 377 participants. RESULTS The median age of the cohort at the time of analysis was 8.5 years (67% males). There were no statistically significant changes in sIgE level or SPT wheal size after positive OFC to milk, egg, or peanut (n = 20-27 for each food). Change in sIgE level and SPT wheal size was measured after 446 and 453 accidental exposure reactions, respectively. The median change in sIgE level was a decrease of 0.33 kU(A)/L (P < .01) after milk and 0.34 kU(A)/L (P < .01) after egg reactions, but no other statistically significant changes in sIgE level or SPT wheal size were observed for milk, egg, or peanut. When we limited the analysis to only those participants who had diagnostic testing done within 6 months of an accidental exposure reaction, we found that peanut SPT wheal size increased by 1.75 mm (P < .01), but a significant increase was not noted when all participants with testing done within 12 months were considered. CONCLUSIONS The results suggest that reactions from OFCs and accidental exposure are not associated with increases in sensitization among children allergic to milk, egg, or peanut.
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Introduction of potentially allergenic foods in the infant's diet during the first year of life in five European countries.
Schiess, SA, Grote, V, Scaglioni, S, Luque, V, Martin, F, Stolarczyk, A, Vecchi, F, Koletzko, B, ,
Annals of nutrition & metabolism. 2011;(2):109-17
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Abstract
BACKGROUND Little information is available on infants' age at first introduction of potentially allergenic foods as part of complementary feeding. We aimed to analyze age at the introduction of potentially allergenic foods in healthy term infants relative to recommendations in 5 European countries. METHOD Recruitment was conducted from October 2002 to June 2004. A total of 1,678 infants [588 breastfed (BF) and 1,090 formula-fed (FF) infants] were studied. In 1,368 infants, at least one 3-day weighed food diary at the age of 1-9 and 12 completed months was available. RESULTS Six percent of BF infants and 13% of FF infants consumed some potentially allergenic food already prior to the recommended minimum age of 4 months, and 4% of BF infants and 11% of FF infants had already received gluten. There were significant differences in the timing of the introduction of potentially allergenic foods between the countries at the age of 4-6 months (p < 0.001). CONCLUSION The time of first introduction of potentially allergenic foods in infants differed significantly between countries, and they were introduced much earlier than recommended in some countries. FF infants received potentially allergenic foods earlier than BF infants. Better information and counseling of parents is desirable.