Five-year outcomes of the STOP-AD randomised controlled trial: Long-term effects of early emollient therapy in high-risk infants
In brief
Early emollient use halves eczema prevalence at age 5 in high-risk children
In a five-year follow-up of 177 high-risk children, eczema affected 12.3% of those given twice-daily emollient for eight weeks from birth, compared with 24.0% receiving routine skin care; cases were also less severe. Missing follow-up data leave uncertainty about the size of the benefit, so larger studies must confirm whether this brief treatment prevents eczema long term.
- Journal
- Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology (Q1)
- Published
- 1 November 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Molly L Cremin, Sadhbh Hurley, Claire O'Halloran, Maria De Los Angeles Gonzalez, Carol Ni Chaoimh, Roberto Velasco Zuniga, et al.
- PMID
- 42973282
- DOI
- 10.1111/pai.70517
Why clinicians should know about it
- Picked for Dermatology (paper of the day, 4 November 2026): Long-term randomized evidence on early emollients and atopic dermatitis
- Picked for Pediatrics and Child Health (paper of the day, 4 November 2026): Randomized trial follow-up tests infant emollients for childhood eczema prevention
- Picked for Immunology and Allergy (paper of the day, 4 November 2026): early emollient lowers 5‑year AD prevalence
Abstract
BACKGROUND: Early-life skin barrier enhancement has been proposed as a strategy to prevent atopic dermatitis (AD), but results from emollient prevention trials have been inconsistent, and long-term outcomes remain poorly defined. The STOP-AD trial previously demonstrated a reduction in AD incidence following brief early emollient use in high-risk infants. Whether these effects persist beyond infancy is unknown. METHODS: This study reports the blinded five-year follow-up of the STOP-AD single-centre, randomised controlled trial. Term infants at high risk of AD were randomised within 4 days of birth to either twice-daily whole-body emollient application for the first 8 weeks of life or to standard routine skin care. At 5 years, participants underwent blinded, in-person clinical assessment. AD was diagnosed using UK Working Party Diagnostic Criteria, and disease severity was assessed using SCORAD. Primary outcome was point prevalence of AD at 5 years. Secondary outcomes included AD severity. Complete-case analyses were supplemented by multiple imputation to assess the impact of missing data. RESULTS: A total of 177 children completed the five-year follow-up. The point prevalence of AD at 5 years was lower in the intervention group than in the control group (12.3% vs. 24.0%; RR 0.52, 95% CI 0.26-1.02; p = .048). Among children with AD, disease severity was also lower in the intervention group (median SCORAD 12.0 [IQR 8.2-15.2] vs. 19.6 [IQR 11.8-23.4]; p = .034). Multiple imputation to account for missing outcome data produced a similar treatment effect (OR 0.45, 95% CI 0.19-1.03; p = .060), although with greater uncertainty. CONCLUSIONS: Early, short-term emollient use initiated in the neonatal period was associated with lower AD prevalence and severity at 5 years in high-risk children. Although the effect estimate remained similar following multiple imputation, uncertainty due to attrition remained. These findings suggest that brief early-life barrier support may influence longer-term AD outcomes and support further investigation of the timing and formulation of preventive skin-barrier interventions.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.