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NCT Number: NCT06316609

Prenatal Exposure to Emerging Contaminants and Children's Atopic Dermatitis

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gestational Exposure to Emerging Contaminants (ECs)

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. prenatal exposure to Microplastics at early pregnancy

    Time frame: 12-14 gestational weeks

    Maternal whole blood levels of Microplastics

  33. prenatal exposure to Microplastics at mid pregnancy

    Time frame: 22-26 gestational weeks

    Maternal whole blood levels of Microplastics

  34. prenatal exposure to Microplastics at late pregnancy

    Time frame: 34-36 gestational weeks

    Maternal whole blood levels of Microplastics

  35. prenatal exposure to Microplastics at first trimester

    Time frame: 12-14 gestational weeks

    Maternal serum levels of Microplastics

  36. prenatal exposure to Microplastics at second trimester

    Time frame: 22-26 gestational weeks

    Maternal serum levels of Microplastics

  37. prenatal exposure to Microplastics at third trimester

    Time frame: 34-36 gestational weeks

    Maternal serum levels of Microplastics

  38. Microplastics in Umbilical cord whole blood

    Time frame: at delivery.

    Umbilical cord whole blood levels of Microplastics

  39. Umbilical cord serum Microplastics

    Time frame: at delivery.

    Umbilical cord serum levels of Microplastics

  40. 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

  41. Asthma

    Time frame: incidence of asthma at the age of five.

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

  42. Infantile hemangioma

    Time frame: incidence of Infantile hemangioma at 1 year old

    Diagnosed by dermatologists

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

  • Minhang Maternal and Children Health Care Hospital
  • School of Public Health，Fudan University

Registry information

Official study title

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

Acronym: PECCAD

Important dates

Study start
2016
Primary completion
2018
Study completion
2027
First posted
Mar 18, 2024
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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