AzTrials
AzTrials

Atopic DermatitisPECCADNCT06316609

Prenatal Exposure to Emerging Contaminants and Children's Atopic Dermatitis

An observational study of Atopic Dermatitis, run by Children's Hospital of Fudan University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Atopic Dermatitis
What is being tested?
Gestational Exposure to Emerging Contaminants (ECs)
How many people
456 participants
Where
1 siteChina
Study dates
Jun 2016to 31 Dec 2027
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Children Hospital of Fudan University

    Shanghai, Shanghai Municipality, 201102

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Gestational Exposure to Emerging Contaminants (ECs)
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
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gestational Exposure to Emerging Contaminants (ECs)Other

    Also called Gestational Exposure to Contaminants of Emerging Concern (CECs), Gestational Exposure to Contaminants of Emerging pollutants

    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.

Study groups in NCT06316609
Study groupRoleWhat they receive
participants from birth cohort with ADThe 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.
Receives: Other: Gestational Exposure to Emerging Contaminants (ECs)
participants from birth cohort without ADThe 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.
Receives: Other: Gestational Exposure to Emerging Contaminants (ECs)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at 1 year old

Secondary outcomes (42)
  1. 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.

    Measured: incidence of AD during 6 months after birth

  2. 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.

    Measured: incidence of AD at the age of two.

  3. 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.

    Measured: incidence of AD at the age of five.

  4. 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

    Measured: 12-14 gestational weeks

  5. 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

    Measured: 22-26 gestational weeks

  6. 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

    Measured: 34-36 gestational weeks

  7. 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

    Measured: 12-14 gestational weeks

  8. 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

    Measured: 22-26 gestational weeks

  9. 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

    Measured: 34-36 gestational weeks

  10. 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

    Measured: at delivery

  11. Umbilical cord serum Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs)

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

    Measured: at delivery.

  12. 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

    Measured: 12-14 gestational weeks

  13. 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

    Measured: 22-26 gestational weeks

  14. 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

    Measured: 34-36 gestational weeks

  15. 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

    Measured: 12-14 gestational weeks

  16. 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

    Measured: 22-26 gestational weeks

  17. 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

    Measured: 34-36 gestational weeks

  18. Organophosphate Flame Retardants (OPFRs) in Umbilical cord whole blood

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

    Measured: at delivery

  19. Umbilical cord serum Organophosphate Flame Retardants (OPFRs)

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

    Measured: at delivery

  20. Infant skin barrier function (Transepidermal Water Loss, TEWL)

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

    Measured: infant 24-48 hours

  21. Infant skin barrier function (Transepidermal Water Loss, TEWL)

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

    Measured: infant 42 days old

  22. Infant skin barrier function (Transepidermal Water Loss, TEWL)

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

    Measured: infant 6 months old

  23. Infant skin barrier function (Stratum corneum hydration, SCH)

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

    Measured: infant 24-48 hours

  24. Infant skin barrier function (Stratum corneum hydration, SCH)

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

    Measured: infant 42 days old

  25. Infant skin barrier function (Stratum corneum hydration, SCH)

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

    Measured: infant 6 months old

  26. Infant skin barrier function (sebum content)

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

    Measured: infant 24-48 hours

  27. Infant skin barrier function (sebum content)

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

    Measured: infant 42 days old

  28. Infant skin barrier function (sebum content)

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

    Measured: infant 6 months old

  29. Infant skin barrier function (skin surface pH)

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

    Measured: infant 24-48 hours

  30. Infant skin barrier function (skin surface pH)

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

    Measured: infant 42 days old

  31. Infant skin barrier function (skin surface pH)

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

    Measured: infant 6 months old

  32. prenatal exposure to Microplastics at early pregnancy

    Maternal whole blood levels of Microplastics

    Measured: 12-14 gestational weeks

  33. prenatal exposure to Microplastics at mid pregnancy

    Maternal whole blood levels of Microplastics

    Measured: 22-26 gestational weeks

  34. prenatal exposure to Microplastics at late pregnancy

    Maternal whole blood levels of Microplastics

    Measured: 34-36 gestational weeks

  35. prenatal exposure to Microplastics at first trimester

    Maternal serum levels of Microplastics

    Measured: 12-14 gestational weeks

  36. prenatal exposure to Microplastics at second trimester

    Maternal serum levels of Microplastics

    Measured: 22-26 gestational weeks

  37. prenatal exposure to Microplastics at third trimester

    Maternal serum levels of Microplastics

    Measured: 34-36 gestational weeks

  38. Microplastics in Umbilical cord whole blood

    Umbilical cord whole blood levels of Microplastics

    Measured: at delivery.

  39. Umbilical cord serum Microplastics

    Umbilical cord serum levels of Microplastics

    Measured: at delivery.

  40. Allergic rhinitis

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

    Measured: incidence of allergic rhinitis at the age of five.

  41. Asthma

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

    Measured: incidence of asthma at the age of five.

  42. Infantile hemangioma

    Diagnosed by dermatologists

    Measured: incidence of Infantile hemangioma at 1 year old

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2024
  2. Study startJun 2016
  3. Primary completion30 Apr 2018
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
456 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06316609
Sponsor's protocol ID
AD2016-2027
Acronym
PECCAD
Status last verified
May 2026
First submitted
27 Feb 2024
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

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.

    PubMed 30428139
  • 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.

    PubMed 29343261
  • 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.

    PubMed 24486970

Questions about this trial

What is this clinical trial studying?

An observational study of Atopic Dermatitis, run by Children's Hospital of Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

atopic dermatitis: Infant atopic dermatitis incidence (time frame: at 1 year old). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06316609, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in