Preventive Antenatal Educational Program on Allergic Diseases (PAEPAD) versus standard antenatal care for prevention of atopic dermatitis: study protocol for a single-centre, investigator-blinded randomised controlled trial.

INTRODUCTION

Patient education serves an essential purpose in the long-term management of allergic diseases as a secondary prevention approach. However, evidence on using education for primary prevention is limited. This study aims to evaluate the effect of an educational intervention, that is, the Preventive Antenatal Educational Program on Allergic Diseases (PAEPAD), on infantile allergic disease incidences compared with the standard care.

METHODS AND ANALYSIS

This is a single-centre randomised controlled trial of expecting mother-children dyads in Daxing Teaching Hospital of Beijing, China. A total of 2266 expecting mothers will be recruited. Expecting mothers enlisted in the birth registry of Daxing Teaching Hospital of Capital Medical University and intend to give birth at this location will be screened for eligibility. Women aged≥18 years with less than 14+6 weeks of pregnancy who intends to remain resident in Daxing district for at least 2 years postpartum will be entered into the run-in phase. Randomisation will take place at 30 weeks of gestation. Women at high risk for miscarriage or intend to have abortions will be excluded. The participants will be allocated into two groups (ie, the PAEPAD and the standard care group) by random allocation (1:1). The PAEPAD group will receive a multidisciplinary education of neonatal care, including standard education as the control group and additional information on skincare of infants, sun protection, topical corticosteroids and an overview of atopic dermatitis (AD), whereas the standard care group will receive the standard neonatal care education carried out by obstetricians. Participants will be followed for 2 years. The primary outcome will be infantile AD cumulative incidence at 2 years postpartum. Secondary outcomes will include other AD outcomes, atopic march outcomes, knowledge outcomes and other maternal and neonatal outcomes. Data collection will be carried out using both electronic and paper questionnaires. Biological samples will also be collected longitudinally.

ETHICS AND DISSEMINATION

The study design was approved by the ethical committee of Capital Medical University Daxing Teaching Hospital, Beijing, China. The trial results will be published in peer-reviewed journals and at conferences.

TRIAL REGISTRATION NUMBER

ChiCTR registry (Trial ID: ChiCTR2000040463).