MedPath

Prenatal Exposure to Emerging Contaminants and Children's Atopic Dermatitis

Active, not recruiting
Conditions
Atopic Dermatitis
Interventions
Other: Gestational Exposure to Emerging Contaminants (ECs)
Registration Number
NCT06316609
Lead Sponsor
Children's Hospital of Fudan University
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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
456
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
participants from birth cohort without ADGestational Exposure to Emerging Contaminants (ECs)The association between maternal whole blood and serum levels of Emerging Contaminants (ECs) including Per- and Polyfluoroalkyl Substances (PFASs), Organophosphate Flame Retardants (OPFRs), and Microplastics during pregnancy and the reduced incidence of atopic dermatitis in their offspring.
participants from birth cohort with ADGestational Exposure to Emerging Contaminants (ECs)The association between maternal whole blood and serum levels of Emerging Contaminants (ECs) including Per- and Polyfluoroalkyl Substances (PFASs), Organophosphate Flame Retardants (OPFRs), and Microplastics during pregnancy and the incidence of atopic dermatitis in their offspring.
Primary Outcome Measures
NameTimeMethod
atopic dermatitis: Infant atopic dermatitis incidenceat 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.

Secondary Outcome Measures
NameTimeMethod
Umbilical cord serum Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs)at delivery.

Umbilical cord serum levels of PFDoDA, PFTrDA, PFHpDA, PFBS, PFPeS, PFHxS, PFOS, and PFDS

prenatal exposure to Organophosphate Flame Retardants (OPFRs) at second trimester22-26 gestational weeks

Maternal serum levels of Organophosphate Flame Retardants (OPFRs) comprising 9 variants: TEP、TBP、TBEP/TBOEP、TPrP、TCEP、TCPP/TCIPP、TDCPP/TDCIPP、TDBP/TDBPP、TPhP/TPHP

prenatal exposure to Microplastics at mid pregnancy22-26 gestational weeks

Maternal whole blood levels of Microplastics

Allergic rhinitisincidence of allergic rhinitis at the age of five.

An inquiry into the patient's medical history and electronic medical record

atopic dermatitisincidence of AD at the age of five.

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.

prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at early pregnancy12-14 gestational weeks

Maternal whole blood levels of Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) comprising 15 variants: PFPeA, PFHxA, PFHpA, PFOA, PFNA, PFDA, PFUnDA, PFDoDA, PFTrDA, PFHpDA, PFBS, PFPeS, PFHxS, PFOS, and PFDS

prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at second trimester22-26 gestational weeks

Maternal serum levels of Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) comprising 15 variants: PFPeA, PFHxA, PFHpA, PFOA, PFNA, PFDA, PFUnDA, PFDoDA, PFTrDA, PFHpDA, PFBS, PFPeS, PFHxS, PFOS, and PFDS

prenatal exposure to Organophosphate Flame Retardants (OPFRs) at late pregnancy34-36 gestational weeks

Maternal whole blood levels of Organophosphate Flame Retardants (OPFRs) comprising 9 variants: TEP、TBP、TBEP/TBOEP、TPrP、TCEP、TCPP/TCIPP、TDCPP/TDCIPP、TDBP/TDBPP、TPhP/TPHP

Infant skin barrier function (skin surface pH)infant 6 months old

Skin pH will be evaluated by the device of Multi Probe Adapter 4.

prenatal exposure to Microplastics at late pregnancy34-36 gestational weeks

Maternal whole blood levels of Microplastics

Infantile hemangiomaincidence of Infantile hemangioma at 1 year old

Diagnosed by dermatologists

prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at third trimester34-36 gestational weeks

Maternal serum levels of Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) comprising 15 variants: PFPeA, PFHxA, PFHpA, PFOA, PFNA, PFDA, PFUnDA, PFDoDA, PFTrDA, PFHpDA, PFBS, PFPeS, PFHxS, PFOS, and PFDS

prenatal exposure to Organophosphate Flame Retardants (OPFRs) at early pregnancy12-14 gestational weeks

Maternal whole blood levels of Organophosphate Flame Retardants (OPFRs) comprising 9 variants: TEP、TBP、TBEP/TBOEP、TPrP、TCEP、TCPP/TCIPP、TDCPP/TDCIPP、TDBP/TDBPP、TPhP/TPHP

prenatal exposure to Organophosphate Flame Retardants (OPFRs) at third trimester34-36 gestational weeks

Maternal serum levels of Organophosphate Flame Retardants (OPFRs) comprising 9 variants: TEP、TBP、TBEP/TBOEP、TPrP、TCEP、TCPP/TCIPP、TDCPP/TDCIPP、TDBP/TDBPP、TPhP/TPHP

prenatal exposure to Microplastics at second trimester22-26 gestational weeks

Maternal serum levels of Microplastics

Umbilical cord serum Microplasticsat delivery.

Umbilical cord serum levels of Microplastics

prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at mid pregnancy22-26 gestational weeks

Maternal whole blood levels of Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) comprising 15 variants: PFPeA, PFHxA, PFHpA, PFOA, PFNA, PFDA, PFUnDA, PFDoDA, PFTrDA, PFHpDA, PFBS, PFPeS, PFHxS, PFOS, and PFDS

prenatal exposure to Organophosphate Flame Retardants (OPFRs) at first trimester12-14 gestational weeks

Maternal serum levels of Organophosphate Flame Retardants (OPFRs) comprising 9 variants: TEP、TBP、TBEP/TBOEP、TPrP、TCEP、TCPP/TCIPP、TDCPP/TDCIPP、TDBP/TDBPP、TPhP/TPHP

Infant skin barrier function (Transepidermal Water Loss, TEWL)infant 6 months old

TEWL will be evaluated by the device of Multi Probe Adapter 4.

Microplastics in Umbilical cord whole bloodat delivery.

Umbilical cord whole blood levels of Microplastics

Asthmaincidence of asthma at the age of five.

An inquiry into the patient's medical history and electronic medical record

prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at late pregnancy34-36 gestational weeks

Maternal whole blood levels of Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) comprising 15 variants: PFPeA, PFHxA, PFHpA, PFOA, PFNA, PFDA, PFUnDA, PFDoDA, PFTrDA, PFHpDA, PFBS, PFPeS, PFHxS, PFOS, and PFDS

prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at first trimester12-14 gestational weeks

Maternal serum levels of Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) comprising 15 variants: PFPeA, PFHxA, PFHpA, PFOA, PFNA, PFDA, PFUnDA, PFDoDA, PFTrDA, PFHpDA, PFBS, PFPeS, PFHxS, PFOS, and PFDS

Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) in Umbilical cord whole bloodat delivery

Umbilical cord whole blood levels of PFDoDA, PFTrDA, PFHpDA, PFBS, PFPeS, PFHxS, PFOS, and PFDS

prenatal exposure to Organophosphate Flame Retardants (OPFRs) at mid pregnancy22-26 gestational weeks

Maternal whole blood levels of Organophosphate Flame Retardants (OPFRs) comprising 9 variants: TEP、TBP、TBEP/TBOEP、TPrP、TCEP、TCPP/TCIPP、TDCPP/TDCIPP、TDBP/TDBPP、TPhP/TPHP

Organophosphate Flame Retardants (OPFRs) in Umbilical cord whole bloodat delivery

Umbilical cord whole blood levels of PFDoDA, PFTrDA, PFHpDA, PFBS, PFPeS, PFHxS, PFOS, and PFDS

Umbilical cord serum Organophosphate Flame Retardants (OPFRs)at delivery

Umbilical cord serum levels of PFDoDA, PFTrDA, PFHpDA, PFBS, PFPeS, PFHxS, PFOS, and PFDS

Infant skin barrier function (Stratum corneum hydration, SCH)infant 6 months old

SCH will be evaluated by the device of Multi Probe Adapter 4.

Infant skin barrier function (sebum content)infant 6 months old

Sebum content will be evaluated by the device of Multi Probe Adapter 4.

prenatal exposure to Microplastics at early pregnancy12-14 gestational weeks

Maternal whole blood levels of Microplastics

prenatal exposure to Microplastics at first trimester12-14 gestational weeks

Maternal serum levels of Microplastics

prenatal exposure to Microplastics at third trimester34-36 gestational weeks

Maternal serum levels of Microplastics

Trial Locations

Locations (1)

Children Hospital of Fudan University

🇨🇳

Shanghai, Shanghai, China

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