Prenatal Exposure to Emerging Contaminants and Offspring's Atopic Dermatitis (PECCAD)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 456
- 试验地点
- 1
- 主要终点
- atopic dermatitis: Infant atopic dermatitis incidence
研究概览
简要总结
This prospective cohort study aims to investigate the association between prenatal blood levels of Emerging Contaminants and the five-year incidence of atopic dermatitis (AD) in offspring.
详细描述
This prospective birth cohort study, conducted within the Shanghai prenatal population, involves the collection of maternal blood samples during gestation to directly measure the biological exposure levels of Emerging Contaminants, including Per- and Polyfluoroalkyl Substances (PFAS), Organophosphate Flame Retardants (OPFRs), and Microplastics. Serum and whole blood levels of these contaminants are evaluated during pregnancy at 12-14, 22-26, and 31-34 gestational weeks. Subsequently, the study assesses skin barrier function in infants at 24-48 hours, 42 days, and 6 months of age. During a five-year period, the occurrence of atopic dermatitis (AD) in offspring is assessed. The objectives of this cohort study are twofold: (1) to elucidate the relationship between maternal exposure to Emerging Contaminants and the development of AD in offspring, and (2) to evaluate the impact of such exposure on the skin barrier function of infants. This research aims to provide substantial evidence for the prevention of AD, offering a unique and meaningful approach to mitigating the incidence of AD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mother plans to proceed prenatal care and delivery in Minhang Maternal and Children Health Care Hospital
- •12-14 weeks of singleton pregnancy, non-stillborn or miscarrying, offspring without familial hereditary skin diseases
- •Offspring plans to stay in Shanghai until 5 years and proceed follow-up at the Dermatology Department of Children's Hospital affiliated with Fudan University
- •signed informed consent.
排除标准
- •Multiple pregnancies
- •perinatal death
- •a fetus with congenital skin or appendages disorders
结局指标
主要结局
atopic dermatitis: Infant atopic dermatitis incidence
时间窗: at 1 year old
Disease diagnosis according to the criteria of Williams. Skin status was examined via onsite interview by pediatric dermatologists. Parents consulted or visited a dermatologist once their baby developed any skin symptoms.
次要结局
- Umbilical cord serum Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs)(at delivery.)
- prenatal exposure to Organophosphate Flame Retardants (OPFRs) at second trimester(22-26 gestational weeks)
- prenatal exposure to Microplastics at mid pregnancy(22-26 gestational weeks)
- Allergic rhinitis(incidence of allergic rhinitis at the age of five.)
- atopic dermatitis(incidence of AD at the age of five.)
- prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at early pregnancy(12-14 gestational weeks)
- prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at second trimester(22-26 gestational weeks)
- prenatal exposure to Organophosphate Flame Retardants (OPFRs) at late pregnancy(34-36 gestational weeks)
- Infant skin barrier function (skin surface pH)(infant 6 months old)
- prenatal exposure to Microplastics at late pregnancy(34-36 gestational weeks)
- Infantile hemangioma(incidence of Infantile hemangioma at 1 year old)
- prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at third trimester(34-36 gestational weeks)
- prenatal exposure to Organophosphate Flame Retardants (OPFRs) at early pregnancy(12-14 gestational weeks)
- prenatal exposure to Organophosphate Flame Retardants (OPFRs) at third trimester(34-36 gestational weeks)
- prenatal exposure to Microplastics at second trimester(22-26 gestational weeks)
- Umbilical cord serum Microplastics(at delivery.)
- prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at mid pregnancy(22-26 gestational weeks)
- prenatal exposure to Organophosphate Flame Retardants (OPFRs) at first trimester(12-14 gestational weeks)
- Infant skin barrier function (Transepidermal Water Loss, TEWL）(infant 6 months old)
- Microplastics in Umbilical cord whole blood(at delivery.)
- Asthma(incidence of asthma at the age of five.)
- prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at late pregnancy(34-36 gestational weeks)
- prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at first trimester(12-14 gestational weeks)
- Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) in Umbilical cord whole blood(at delivery)
- prenatal exposure to Organophosphate Flame Retardants (OPFRs) at mid pregnancy(22-26 gestational weeks)
- Organophosphate Flame Retardants (OPFRs) in Umbilical cord whole blood(at delivery)
- Umbilical cord serum Organophosphate Flame Retardants (OPFRs)(at delivery)
- Infant skin barrier function (Stratum corneum hydration, SCH)(infant 6 months old)
- Infant skin barrier function (sebum content)(infant 6 months old)
- prenatal exposure to Microplastics at early pregnancy(12-14 gestational weeks)
- prenatal exposure to Microplastics at first trimester(12-14 gestational weeks)
- prenatal exposure to Microplastics at third trimester(34-36 gestational weeks)