PreventADALL Trial

PreventADALL (Preventing Atopic Dermatitis and ALLergies in children) is a large population-based prevention trial run in Oslo and Østfold, Norway, and Stockholm, Sweden. Between 2015 and 2017, 2,397 newborns from the general population (not only high-risk families) were cluster-randomised at birth into four groups using a 2×2 factorial design: no intervention; a skin intervention of a paraffin bath oil plus a facial cream at least 4 days a week from 2 weeks to about 9 months (Emollient Bath Additives, Mineral Oil); a food intervention of tastes of peanut, cow’s milk, wheat and egg from 3–4 months; or both (Skjerven, Lancet 2020). Investigators who did not know the group assignment diagnosed eczema using the UK Working Party Criteria and Hanifin-Rajka Criteria.

PreventADALL Trial [relates] Emollient Therapy PreventADALL Trial [relates] Dual-Allergen Exposure Hypothesis

Eczema result (age 12 months): emollients did not prevent it. Atopic Dermatitis developed in 8% of the no-intervention group, 11% of the skin group, 9% of the food group and 5% of the combined group. Neither intervention reduced eczema. The risk difference for the skin intervention was 3.1% in favour of control, but the 95% confidence interval ran from −0.3% to 6.5%, so the trial did not show a statistically significant increase either. Skin symptoms were no more frequent in any intervention group. Together with the BEEP Trial, the result fed into the Cochrane review (Kelleher 2022) concluding that regular infant emollients “probably” do not prevent eczema.

PreventADALL Trial [contradicts] Petrolatum PreventADALL Trial [supports] BEEP Trial

Conflict: [Medicina review, 2024] says emollient use “mildly increased the risk of AD (3.1%, 95% CI: 0.3% to 6.5%)“. [Skjerven et al., Lancet, 2020, primary report] gives the same 3.1% risk difference with a 95% CI of −0.3 to 6.5, meaning no statistically significant change. Unresolved — add to open_questions. The primary trial paper is the more reliable figure; the vault treats the effect as “no benefit, possible small harm not proven”.

Food allergy result (age 36 months): early foods helped, emollients did not. Food allergy was diagnosed in 2.3% of the no-intervention group, 3.0% of the skin group, 0.9% of the food group and 1.2% of the combined group (Skjerven, Lancet 2022). Early food introduction from 3 months reduced Food Allergy (risk difference −1.6%; OR 0.4), with 63 infants needing early feeding to prevent one case. Most cases were peanut allergy (32 of 44). Emollients gave no protection (OR 1.3). This adds a general-population result to the high-risk LEAP Trial and the EAT Trial, and it does not support the idea that moisturising alone blocks skin-route sensitisation.

PreventADALL Trial [supports] LEAP Trial PreventADALL Trial [prevents] Food Allergy

What it means for toddler parents. By toddlerhood the prevention question is past, but the trial still matters. Emollients remain the base of treating eczema (Emollient Therapy), even though they did not prevent it in healthy babies. Families should not feel that missed moisturising in infancy caused their child’s eczema. Reviewers point to low adherence, the start age and the type of product (bath oil rather than ceramide-rich creams such as those in the PEBBLES pilot; see Ceramides) as possible reasons for the null result (J Clin Med 2022). Bringing common allergenic foods into the diet early, rather than holding them back, is the finding that carries over most directly into everyday feeding.

PreventADALL Trial [relates] Ceramides PreventADALL Trial [contradicts] Elimination Diets

Connections

• BEEP Trial — companion negative prevention trial, source: Medicina 2024; Skjerven 2020
• Atopic March — Medicina 2024 reports slightly raised AD risk; primary paper CI crosses zero, source: Medicina 2024; Skjerven 2020
• Emollient Therapy — skin emollients from 2 weeks did not prevent AD by 12 months, source: Skjerven Lancet 2020
• Food Allergy — early allergenic foods cut food allergy at 36 months (NNT 63), source: Skjerven Lancet 2022
• LEAP Trial — consistent early-introduction benefit in a general population, source: Skjerven 2022
• Petrolatum — paraffin-based emollient prevention not confirmed, source: J Clin Med 2022 review
• Cochrane — included in Kelleher 2022 null prevention review, source: Cochrane 2022
• Dual-Allergen Exposure Hypothesis — skin-barrier arm did not reduce food allergy; oral arm did, source: Skjerven 2022