Preventive Prenatal Educational Program on Allergic Diseases (PAEPAD) versus standard prenatal care for the prevention of atopic dermatitis: study protocol for a single-center, investigator-blinded randomized controlled trial

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BMJ open. 2022 Jan 25;12(1):e048083. doi: 10.1136/bmjopen-2020-048083.

ABSTRACT

INTRODUCTION: Patient education is an essential goal in the long-term management of allergic disease as a secondary prevention approach. However, evidence on the use of education for primary prevention is limited. This study aims to assess the effect of an educational intervention, i.e. the Prenatal Educational Program for Allergic Diseases (PAEPAD), on the incidence of childhood allergic diseases compared to standard care.

METHODS AND ANALYSIS: This is a single-center randomized controlled trial of pregnant mother-infant dyads at Daxing University Hospital in Beijing, China. A total of 2,266 pregnant women will be recruited. Expectant mothers registered in the birth registry of Daxing Teaching Hospital of Capital Medical University and who intend to give birth there will be reviewed for eligibility. Women aged ≥ 18 years with less than 14 + 6 weeks of pregnancy who intend to remain residents in Daxing District for at least 2 years after giving birth will have entered the running-in phase. Randomization will take place at 30 weeks of gestation. Women at high risk of miscarriage or intending to abort will be excluded. Participants will be divided into two groups (i.e. PAEPAD group and standard care group) by random assignment (1:1). The PAEPAD group will receive multidisciplinary training in neonatal care, including standard training as a control group and additional information on infant skin care, sun protection, topical corticosteroids, and an overview of atopic dermatitis ( DA), while the standard care group will receive standard training in neonatal care from obstetricians. Participants will be followed for 2 years. The primary endpoint will be the cumulative incidence of infantile AD at 2 years postpartum. Secondary outcomes will include other AD outcomes, atopic walk outcomes, knowledge outcomes, and other maternal and neonatal outcomes. Data collection will be carried out using electronic and paper questionnaires. Biological samples will also be taken longitudinally.

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

TRIAL REGISTRATION NUMBER: ChiCTR Registry (Trial ID: ChiCTR2000040463).

PMID:35078832 | DOI:10.1136/bmjopen-2020-048083

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