Prenatal Exposure to Emerging Contaminants and Children's Atopic Dermatitis (PECCAD)

Prenatal Exposure to Emerging Contaminants and Offspring's Atopic Dermatitis (PECCAD)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Gestational Exposure to Emerging Contaminants (ECs)

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.

• Study Type: Observational
• Enrollment (Actual): 456

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201102
      • Children Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
participants from birth cohort with AD; 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.	Other: Gestational Exposure to Emerging Contaminants (ECs); Levels of Emerging Contaminants (ECs), such as Per- and Polyfluoroalkyl Substances (PFASs), Organophosphate Flame Retardants (OPFRs), and Microplastics, are assessed in maternal blood and umbilical cord blood during gestation.; Other Names: Gestational Exposure to Contaminants of Emerging Concern (CECs); Gestational Exposure to Contaminants of Emerging pollutants
participants from birth cohort without AD; 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.	Other: Gestational Exposure to Emerging Contaminants (ECs); Levels of Emerging Contaminants (ECs), such as Per- and Polyfluoroalkyl Substances (PFASs), Organophosphate Flame Retardants (OPFRs), and Microplastics, are assessed in maternal blood and umbilical cord blood during gestation.; Other Names: Gestational Exposure to Contaminants of Emerging Concern (CECs); Gestational Exposure to Contaminants of Emerging pollutants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
atopic dermatitis: Infant atopic dermatitis incidence	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.	at 1 year old

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant skin barrier function (Transepidermal Water Loss, TEWL）	TEWL will be evaluated by the device of Multi Probe Adapter 4.	infant 24-48 hours
Infant skin barrier function (Transepidermal Water Loss, TEWL）	TEWL will be evaluated by the device of Multi Probe Adapter 4.	infant 42 days old
Infant skin barrier function (Transepidermal Water Loss, TEWL）	TEWL will be evaluated by the device of Multi Probe Adapter 4.	infant 6 months old
Infant skin barrier function (Stratum corneum hydration, SCH)	SCH will be evaluated by the device of Multi Probe Adapter 4.	infant 24-48 hours
Infant skin barrier function (Stratum corneum hydration, SCH)	SCH will be evaluated by the device of Multi Probe Adapter 4.	infant 42 days old
Infant skin barrier function (Stratum corneum hydration, SCH)	SCH will be evaluated by the device of Multi Probe Adapter 4.	infant 6 months old
Infant skin barrier function (skin surface pH)	Skin pH will be evaluated by the device of Multi Probe Adapter 4.	infant 24-48 hours
Infant skin barrier function (skin surface pH)	Skin pH will be evaluated by the device of Multi Probe Adapter 4.	infant 42 days old
Infant skin barrier function (skin surface pH)	Skin pH will be evaluated by the device of Multi Probe Adapter 4.	infant 6 months old
Infant skin barrier function (sebum content)	Sebum content will be evaluated by the device of Multi Probe Adapter 4.	infant 24-48 hours
Infant skin barrier function (sebum content)	Sebum content will be evaluated by the device of Multi Probe Adapter 4.	infant 42 days old
Infant skin barrier function (sebum content)	Sebum content will be evaluated by the device of Multi Probe Adapter 4.	infant 6 months old
atopic dermatitis	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.	incidence of AD during 6 months after birth
atopic dermatitis	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.	incidence of AD at the age of two.
atopic dermatitis	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.	incidence of AD at the age of five.
prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at early pregnancy	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	12-14 gestational weeks
prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at mid pregnancy	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	22-26 gestational weeks
prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at late pregnancy	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	34-36 gestational weeks
prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at first trimester	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	12-14 gestational weeks
prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at second trimester	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	22-26 gestational weeks
prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at third trimester	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	34-36 gestational weeks
Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) in Umbilical cord whole blood	Umbilical cord whole blood levels of PFDoDA, PFTrDA, PFHpDA, PFBS, PFPeS, PFHxS, PFOS, and PFDS	at delivery
Umbilical cord serum Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs)	Umbilical cord serum levels of PFDoDA, PFTrDA, PFHpDA, PFBS, PFPeS, PFHxS, PFOS, and PFDS	at delivery.
prenatal exposure to Organophosphate Flame Retardants (OPFRs) at early pregnancy	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	12-14 gestational weeks
prenatal exposure to Organophosphate Flame Retardants (OPFRs) at mid pregnancy	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	22-26 gestational weeks
prenatal exposure to Organophosphate Flame Retardants (OPFRs) at late pregnancy	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	34-36 gestational weeks
prenatal exposure to Organophosphate Flame Retardants (OPFRs) at first trimester	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	12-14 gestational weeks
prenatal exposure to Organophosphate Flame Retardants (OPFRs) at second trimester	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	22-26 gestational weeks
prenatal exposure to Organophosphate Flame Retardants (OPFRs) at third trimester	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	34-36 gestational weeks
Organophosphate Flame Retardants (OPFRs) in Umbilical cord whole blood	Umbilical cord whole blood levels of PFDoDA, PFTrDA, PFHpDA, PFBS, PFPeS, PFHxS, PFOS, and PFDS	at delivery
Umbilical cord serum Organophosphate Flame Retardants (OPFRs)	Umbilical cord serum levels of PFDoDA, PFTrDA, PFHpDA, PFBS, PFPeS, PFHxS, PFOS, and PFDS	at delivery
prenatal exposure to Microplastics at early pregnancy	Maternal whole blood levels of Microplastics	12-14 gestational weeks
prenatal exposure to Microplastics at mid pregnancy	Maternal whole blood levels of Microplastics	22-26 gestational weeks
prenatal exposure to Microplastics at late pregnancy	Maternal whole blood levels of Microplastics	34-36 gestational weeks
prenatal exposure to Microplastics at first trimester	Maternal serum levels of Microplastics	12-14 gestational weeks
prenatal exposure to Microplastics at second trimester	Maternal serum levels of Microplastics	22-26 gestational weeks
prenatal exposure to Microplastics at third trimester	Maternal serum levels of Microplastics	34-36 gestational weeks
Microplastics in Umbilical cord whole blood	Umbilical cord whole blood levels of Microplastics	at delivery.
Umbilical cord serum Microplastics	Umbilical cord serum levels of Microplastics	at delivery.
Allergic rhinitis	An inquiry into the patient's medical history and electronic medical record	incidence of allergic rhinitis at the age of five.
Asthma	An inquiry into the patient's medical history and electronic medical record	incidence of asthma at the age of five.
Infantile hemangioma	Diagnosed by dermatologists	incidence of Infantile hemangioma at 1 year old

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Collaborators: School of Public Health，Fudan University; Minhang Maternal and Children Health Care Hospital
• Investigators: Principal Investigator: Ying Ye, MD,PhD, Children's Hospital of Fudan University Shanghai, China, 201102

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): April 30, 2018
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cohort; Atopic Dermatitis; Maternal; Birth; Microplastics; Skin barrier; Organophosphate Flame Retardants, OPFRs; Perfluoroalkyl and Polyfluoroalkyl Substances, PFASs; Contaminants of Emerging Concern, CECs; Emerging Contaminants, ECs
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic
• Other Study ID Numbers: AD2016-2027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No