Clinical trial NCT06316609: Prenatal Exposure to Emerging Contaminants and Children's Atopic Dermatitis
Official title: Prenatal Exposure to Emerging Contaminants and Offspring's Atopic Dermatitis (PECCAD)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atopic Dermatitis
Keywords: Skin barrier
Microplastics
Organophosphate Flame Retardants, OPFRs
Perfluoroalkyl and Polyfluoroalkyl Substances, PFASs
Contaminants of Emerging Concern, CECs
Emerging Contaminants, ECs
Atopic Dermatitis
Maternal
Cohort
Birth
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Minhang Maternal and Children Health Care Hospital
name: School of Public Health，Fudan University
First posted: 2024-03-18
Enrollment: 456
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The research subjects come from the established MKNFOAD birth cohort (NCT 02889081), with on-site inclusion at the early pregnancy outpatient clinic of Minhang Maternal and Child Health Hospital.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Multiple pregnancies
* perinatal death
* a fetus with congenital skin or appendages disorders

Primary outcomes:
measure: atopic dermatitis: Infant atopic dermatitis incidence
timeFrame: at 1 year old
Secondary outcomes:
measure: atopic dermatitis
timeFrame: incidence of AD during 6 months after birth
measure: atopic dermatitis
timeFrame: incidence of AD at the age of two.
measure: atopic dermatitis
timeFrame: incidence of AD at the age of five.
measure: prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at early pregnancy
timeFrame: 12-14 gestational weeks
measure: prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at mid pregnancy
timeFrame: 22-26 gestational weeks
measure: prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at late pregnancy
timeFrame: 34-36 gestational weeks
measure: prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at first trimester
timeFrame: 12-14 gestational weeks
measure: prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at second trimester
timeFrame: 22-26 gestational weeks
measure: prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at third trimester
timeFrame: 34-36 gestational weeks
measure: Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) in Umbilical cord whole blood
timeFrame: at delivery
measure: Umbilical cord serum Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs)
timeFrame: at delivery.
measure: prenatal exposure to Organophosphate Flame Retardants (OPFRs) at early pregnancy
timeFrame: 12-14 gestational weeks
measure: prenatal exposure to Organophosphate Flame Retardants (OPFRs) at mid pregnancy
timeFrame: 22-26 gestational weeks
measure: prenatal exposure to Organophosphate Flame Retardants (OPFRs) at late pregnancy
timeFrame: 34-36 gestational weeks
measure: prenatal exposure to Organophosphate Flame Retardants (OPFRs) at first trimester
timeFrame: 12-14 gestational weeks
measure: prenatal exposure to Organophosphate Flame Retardants (OPFRs) at second trimester
timeFrame: 22-26 gestational weeks
measure: prenatal exposure to Organophosphate Flame Retardants (OPFRs) at third trimester
timeFrame: 34-36 gestational weeks
measure: Organophosphate Flame Retardants (OPFRs) in Umbilical cord whole blood
timeFrame: at delivery
measure: Umbilical cord serum Organophosphate Flame Retardants (OPFRs)
timeFrame: at delivery
measure: Infant skin barrier function (Transepidermal Water Loss, TEWL）
timeFrame: infant 24-48 hours
measure: Infant skin barrier function (Transepidermal Water Loss, TEWL）
timeFrame: infant 42 days old
measure: Infant skin barrier function (Transepidermal Water Loss, TEWL）
timeFrame: infant 6 months old
measure: Infant skin barrier function (Stratum corneum hydration, SCH)
timeFrame: infant 24-48 hours
measure: Infant skin barrier function (Stratum corneum hydration, SCH)
timeFrame: infant 42 days old
measure: Infant skin barrier function (Stratum corneum hydration, SCH)
timeFrame: infant 6 months old
measure: Infant skin barrier function (sebum content)
timeFrame: infant 24-48 hours
measure: Infant skin barrier function (sebum content)
timeFrame: infant 42 days old
measure: Infant skin barrier function (sebum content)
timeFrame: infant 6 months old
measure: Infant skin barrier function (skin surface pH)
timeFrame: infant 24-48 hours
measure: Infant skin barrier function (skin surface pH)
timeFrame: infant 42 days old
measure: Infant skin barrier function (skin surface pH)
timeFrame: infant 6 months old
measure: prenatal exposure to Microplastics at early pregnancy
timeFrame: 12-14 gestational weeks
measure: prenatal exposure to Microplastics at mid pregnancy
timeFrame: 22-26 gestational weeks
measure: prenatal exposure to Microplastics at late pregnancy
timeFrame: 34-36 gestational weeks
measure: prenatal exposure to Microplastics at first trimester
timeFrame: 12-14 gestational weeks
measure: prenatal exposure to Microplastics at second trimester
timeFrame: 22-26 gestational weeks
measure: prenatal exposure to Microplastics at third trimester
timeFrame: 34-36 gestational weeks
measure: Microplastics in Umbilical cord whole blood
timeFrame: at delivery.
measure: Umbilical cord serum Microplastics
timeFrame: at delivery.
measure: Allergic rhinitis
timeFrame: incidence of allergic rhinitis at the age of five.
measure: Asthma
timeFrame: incidence of asthma at the age of five.
measure: Infantile hemangioma
timeFrame: incidence of Infantile hemangioma at 1 year old
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University Shanghai, China, 201102
name: Ying Ye, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lowe AJ, Dharmage SC, Abramson MJ, Vijayasarathy S, Erbas B, Mueller JF, Lodge CJ. Cord-serum per- and poly-fluoroalkyl substances and atopy and eczema at 12-months. Allergy. 2019 Apr;74(4):812-815. doi: 10.1111/all.13669. Epub 2018 Dec 4. No abstract available.
citation: Chen Q, Huang R, Hua L, Guo Y, Huang L, Zhao Y, Wang X, Zhang J. Prenatal exposure to perfluoroalkyl and polyfluoroalkyl substances and childhood atopic dermatitis: a prospective birth cohort study. Environ Health. 2018 Jan 17;17(1):8. doi: 10.1186/s12940-018-0352-7.
citation: Okada E, Sasaki S, Kashino I, Matsuura H, Miyashita C, Kobayashi S, Itoh K, Ikeno T, Tamakoshi A, Kishi R. Prenatal exposure to perfluoroalkyl acids and allergic diseases in early childhood. Environ Int. 2014 Apr;65:127-34. doi: 10.1016/j.envint.2014.01.007. Epub 2014 Jan 29.