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

May 13, 2026 updated by: Children's Hospital of Fudan University

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
456

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
atopic dermatitis: Infant atopic dermatitis incidence
Time Frame: 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.
at 1 year old

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Infant skin barrier function (Transepidermal Water Loss, TEWL）
Time Frame: infant 24-48 hours
TEWL will be evaluated by the device of Multi Probe Adapter 4.
infant 24-48 hours
Infant skin barrier function (Transepidermal Water Loss, TEWL）
Time Frame: infant 42 days old
TEWL will be evaluated by the device of Multi Probe Adapter 4.
infant 42 days old
Infant skin barrier function (Transepidermal Water Loss, TEWL）
Time Frame: infant 6 months old
TEWL will be evaluated by the device of Multi Probe Adapter 4.
infant 6 months old
Infant skin barrier function (Stratum corneum hydration, SCH)
Time Frame: infant 24-48 hours
SCH will be evaluated by the device of Multi Probe Adapter 4.
infant 24-48 hours
Infant skin barrier function (Stratum corneum hydration, SCH)
Time Frame: infant 42 days old
SCH will be evaluated by the device of Multi Probe Adapter 4.
infant 42 days old
Infant skin barrier function (Stratum corneum hydration, SCH)
Time Frame: infant 6 months old
SCH will be evaluated by the device of Multi Probe Adapter 4.
infant 6 months old
Infant skin barrier function (skin surface pH)
Time Frame: infant 24-48 hours
Skin pH will be evaluated by the device of Multi Probe Adapter 4.
infant 24-48 hours
Infant skin barrier function (skin surface pH)
Time Frame: infant 42 days old
Skin pH will be evaluated by the device of Multi Probe Adapter 4.
infant 42 days old
Infant skin barrier function (skin surface pH)
Time Frame: infant 6 months old
Skin pH will be evaluated by the device of Multi Probe Adapter 4.
infant 6 months old
Infant skin barrier function (sebum content)
Time Frame: infant 24-48 hours
Sebum content will be evaluated by the device of Multi Probe Adapter 4.
infant 24-48 hours
Infant skin barrier function (sebum content)
Time Frame: infant 42 days old
Sebum content will be evaluated by the device of Multi Probe Adapter 4.
infant 42 days old
Infant skin barrier function (sebum content)
Time Frame: infant 6 months old
Sebum content will be evaluated by the device of Multi Probe Adapter 4.
infant 6 months old
atopic dermatitis
Time Frame: incidence of AD during 6 months after birth
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
Time Frame: incidence of AD at the age of two.
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
Time Frame: incidence 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.
incidence of AD at the age of five.
prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at early pregnancy
Time Frame: 12-14 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
12-14 gestational weeks
prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at mid pregnancy
Time Frame: 22-26 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
22-26 gestational weeks
prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at late pregnancy
Time Frame: 34-36 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
34-36 gestational weeks
prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at first trimester
Time Frame: 12-14 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
12-14 gestational weeks
prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at second trimester
Time Frame: 22-26 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
22-26 gestational weeks
prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at third trimester
Time Frame: 34-36 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
34-36 gestational weeks
Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) in Umbilical cord whole blood
Time Frame: at delivery
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)
Time Frame: at delivery.
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
Time Frame: 12-14 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
12-14 gestational weeks
prenatal exposure to Organophosphate Flame Retardants (OPFRs) at mid pregnancy
Time Frame: 22-26 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
22-26 gestational weeks
prenatal exposure to Organophosphate Flame Retardants (OPFRs) at late pregnancy
Time Frame: 34-36 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
34-36 gestational weeks
prenatal exposure to Organophosphate Flame Retardants (OPFRs) at first trimester
Time Frame: 12-14 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
12-14 gestational weeks
prenatal exposure to Organophosphate Flame Retardants (OPFRs) at second trimester
Time Frame: 22-26 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
22-26 gestational weeks
prenatal exposure to Organophosphate Flame Retardants (OPFRs) at third trimester
Time Frame: 34-36 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
34-36 gestational weeks
Organophosphate Flame Retardants (OPFRs) in Umbilical cord whole blood
Time Frame: at delivery
Umbilical cord whole blood levels of PFDoDA, PFTrDA, PFHpDA, PFBS, PFPeS, PFHxS, PFOS, and PFDS
at delivery
Umbilical cord serum Organophosphate Flame Retardants (OPFRs)
Time Frame: at delivery
Umbilical cord serum levels of PFDoDA, PFTrDA, PFHpDA, PFBS, PFPeS, PFHxS, PFOS, and PFDS
at delivery
prenatal exposure to Microplastics at early pregnancy
Time Frame: 12-14 gestational weeks
Maternal whole blood levels of Microplastics
12-14 gestational weeks
prenatal exposure to Microplastics at mid pregnancy
Time Frame: 22-26 gestational weeks
Maternal whole blood levels of Microplastics
22-26 gestational weeks
prenatal exposure to Microplastics at late pregnancy
Time Frame: 34-36 gestational weeks
Maternal whole blood levels of Microplastics
34-36 gestational weeks
prenatal exposure to Microplastics at first trimester
Time Frame: 12-14 gestational weeks
Maternal serum levels of Microplastics
12-14 gestational weeks
prenatal exposure to Microplastics at second trimester
Time Frame: 22-26 gestational weeks
Maternal serum levels of Microplastics
22-26 gestational weeks
prenatal exposure to Microplastics at third trimester
Time Frame: 34-36 gestational weeks
Maternal serum levels of Microplastics
34-36 gestational weeks
Microplastics in Umbilical cord whole blood
Time Frame: at delivery.
Umbilical cord whole blood levels of Microplastics
at delivery.
Umbilical cord serum Microplastics
Time Frame: at delivery.
Umbilical cord serum levels of Microplastics
at delivery.
Allergic rhinitis
Time Frame: incidence of allergic rhinitis at the age of five.
An inquiry into the patient's medical history and electronic medical record
incidence of allergic rhinitis at the age of five.
Asthma
Time Frame: incidence of asthma at the age of five.
An inquiry into the patient's medical history and electronic medical record
incidence of asthma at the age of five.
Infantile hemangioma
Time Frame: incidence of Infantile hemangioma at 1 year old
Diagnosed by dermatologists
incidence of Infantile hemangioma at 1 year old

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Fudan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
School of Public Health，Fudan University
Minhang Maternal and Children Health Care Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ying Ye, MD,PhD, Children's Hospital of Fudan University Shanghai, China, 201102

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2018

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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