Five-year outcomes of the STOP-AD randomised controlled trial: Long-term effects of early emollient therapy in high-risk infants.
6 affiliations
- 1Irish Centre for Maternal and Child Health Research (INFANT), HRB Clinical Research Facility Cork (CRF-C), Cork, Ireland.
- 2Paediatrics and Child Health, University College Cork, Cork, Ireland.
- 3Paediatrics, Cork University Hospital, Cork, Ireland.
- 4Clinical Medicine, Trinity College Dublin, Dublin, Ireland.
- 5Paediatrics and Child Health, Royal College of Surgeons in Ireland, Dublin, Ireland.
- 6Children's Health Ireland, Dublin, Ireland.
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.
Related
- Heating On Transport WitH prEtErm and Low birth weight infants using servocontrol thermoregulation (HOTWHEELS): study protocol for a randomised controlled trial.
- Food supplementation and behavioural counselling to reduce the double burden of malnutrition among pregnant women and their infants: protocol for the K’ASLEM hybrid type 1 effectiveness-implementation randomised controlled trial
- Comparative efficacy of extracorporeal shockwave therapy versus low-level laser therapy for myogenous temporomandibular disorders: a randomised controlled trial protocol
- Cost-effectiveness of adjunctive hyperbaric oxygen therapy for fibromyalgia: an economic evaluation alongside a single-centre randomised controlled trial in Brazil
- Evaluating 20-session augmented depression therapy for complex depression (ADepT+) versus usual care: a study protocol for a feasibility randomised controlled trial
BibTeX
@article{cremin2026fiveyear,
title = {{Five-year outcomes of the STOP-AD randomised controlled trial: Long-term effects of early emollient therapy in high-risk infants.}},
author = {Molly L Cremin and Sadhbh Hurley and Claire O'Halloran and Maria De Los Angeles Gonzalez and Carol Ni Chaoimh and Roberto Velasco Zuniga and Juan Trujillo and Alan D Irvine and Jonathan O'B Hourihane},
journal = {Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology},
year = {2026},
month = nov,
doi = {10.1111/pai.70517},
url = {https://europepmc.org/article/MED/42973282},
note = {CC BY},
}
RIS
TY - JOUR
TI - Five-year outcomes of the STOP-AD randomised controlled trial: Long-term effects of early emollient therapy in high-risk infants.
AU - Molly L Cremin
AU - Sadhbh Hurley
AU - Claire O'Halloran
AU - Maria De Los Angeles Gonzalez
AU - Carol Ni Chaoimh
AU - Roberto Velasco Zuniga
AU - Juan Trujillo
AU - Alan D Irvine
AU - Jonathan O'B Hourihane
PY - 2026
DA - 2026/11/01
JO - Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology
DO - 10.1111/pai.70517
UR - https://europepmc.org/article/MED/42973282
AB - 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.
SN - 0905-6157
SN - 1399-3038
ER -