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.
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
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.
- Conditions
- Atopic Dermatitis
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Gestational Exposure to Emerging Contaminants (ECs) | |
| 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. 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.
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)
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
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.
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.
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
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
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
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
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
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
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
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.
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
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
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
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
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
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
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
Umbilical cord serum Organophosphate Flame Retardants (OPFRs)
Umbilical cord serum levels of PFDoDA, PFTrDA, PFHpDA, PFBS, PFPeS, PFHxS, PFOS, and PFDS
Measured: at delivery
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
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
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
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
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
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
Infant skin barrier function (sebum content)
Sebum content will be evaluated by the device of Multi Probe Adapter 4.
Measured: infant 24-48 hours
Infant skin barrier function (sebum content)
Sebum content will be evaluated by the device of Multi Probe Adapter 4.
Measured: infant 42 days old
Infant skin barrier function (sebum content)
Sebum content will be evaluated by the device of Multi Probe Adapter 4.
Measured: infant 6 months old
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
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
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
prenatal exposure to Microplastics at early pregnancy
Maternal whole blood levels of Microplastics
Measured: 12-14 gestational weeks
prenatal exposure to Microplastics at mid pregnancy
Maternal whole blood levels of Microplastics
Measured: 22-26 gestational weeks
prenatal exposure to Microplastics at late pregnancy
Maternal whole blood levels of Microplastics
Measured: 34-36 gestational weeks
prenatal exposure to Microplastics at first trimester
Maternal serum levels of Microplastics
Measured: 12-14 gestational weeks
prenatal exposure to Microplastics at second trimester
Maternal serum levels of Microplastics
Measured: 22-26 gestational weeks
prenatal exposure to Microplastics at third trimester
Maternal serum levels of Microplastics
Measured: 34-36 gestational weeks
Microplastics in Umbilical cord whole blood
Umbilical cord whole blood levels of Microplastics
Measured: at delivery.
Umbilical cord serum Microplastics
Umbilical cord serum levels of Microplastics
Measured: at delivery.
Allergic rhinitis
An inquiry into the patient's medical history and electronic medical record
Measured: incidence of allergic rhinitis at the age of five.
Asthma
An inquiry into the patient's medical history and electronic medical record
Measured: incidence of asthma at the age of five.
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.
- First posted18 Mar 2024
- Study startJun 2016
- Primary completion30 Apr 2018
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Minhang Maternal and Children Health Care Hospital, School of Public Health,Fudan University
- Responsible party
- Sponsor
- Investigators
- Ying Ye, MD,PhD, Principal investigator, Children's Hospital of Fudan University Shanghai, China, 201102
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 30428139Chen 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 29343261Okada 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
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Exposure to Emerging Contaminants and Offspring's Atopic Dermatitis (PECCAD)
- ClinicalTrials.gov ID
- NCT06316609
- Acronym / sponsor ID
- PECCAD / AD2016-2027
- Conditions
- Atopic Dermatitis
- Keywords
- Skin barrier, Microplastics, Organophosphate Flame Retardants, OPFRs, Perfluoroalkyl and Polyfluoroalkyl Substances, PFASs, Contaminants of Emerging Concern, CECs, Emerging Contaminants, ECs, Atopic Dermatitis, Maternal
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 456 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Minhang Maternal and Children Health Care Hospital, School of Public Health,Fudan University
- Study start
- Jun 2016 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| participants from birth cohort with AD | – | Other: Gestational 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. |
| participants from birth cohort without AD | – | Other: Gestational 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Multiple pregnancies
- perinatal death
- a fetus with congenital skin or appendages disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gestational Exposure to Emerging Contaminants (ECs)Also: Gestational Exposure to Contaminants of Emerging Concern (CECs), Gestational Exposure to Contaminants of Emerging pollutantsLevels 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 | participants from birth cohort with AD, participants from birth cohort without AD |
Primary outcome
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.
42 secondary outcomes
atopic dermatitis
Time frame: incidence of AD during 6 months after birth
atopic dermatitis
Time frame: incidence of AD at the age of two.
atopic dermatitis
Time frame: 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
prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at mid pregnancy
Time frame: 22-26 gestational weeks
prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at late pregnancy
Time frame: 34-36 gestational weeks
prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at first trimester
Time frame: 12-14 gestational weeks
prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at second trimester
Time frame: 22-26 gestational weeks
prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at third trimester
Time frame: 34-36 gestational weeks
Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) in Umbilical cord whole blood
Time frame: at delivery
Umbilical cord serum Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs)
Time frame: at delivery.
prenatal exposure to Organophosphate Flame Retardants (OPFRs) at early pregnancy
Time frame: 12-14 gestational weeks
prenatal exposure to Organophosphate Flame Retardants (OPFRs) at mid pregnancy
Time frame: 22-26 gestational weeks
prenatal exposure to Organophosphate Flame Retardants (OPFRs) at late pregnancy
Time frame: 34-36 gestational weeks
prenatal exposure to Organophosphate Flame Retardants (OPFRs) at first trimester
Time frame: 12-14 gestational weeks
prenatal exposure to Organophosphate Flame Retardants (OPFRs) at second trimester
Time frame: 22-26 gestational weeks
prenatal exposure to Organophosphate Flame Retardants (OPFRs) at third trimester
Time frame: 34-36 gestational weeks
Organophosphate Flame Retardants (OPFRs) in Umbilical cord whole blood
Time frame: at delivery
Umbilical cord serum Organophosphate Flame Retardants (OPFRs)
Time frame: at delivery
Infant skin barrier function (Transepidermal Water Loss, TEWL)
Time frame: infant 24-48 hours
Infant skin barrier function (Transepidermal Water Loss, TEWL)
Time frame: infant 42 days old
Infant skin barrier function (Transepidermal Water Loss, TEWL)
Time frame: infant 6 months old
Infant skin barrier function (Stratum corneum hydration, SCH)
Time frame: infant 24-48 hours
Infant skin barrier function (Stratum corneum hydration, SCH)
Time frame: infant 42 days old
Infant skin barrier function (Stratum corneum hydration, SCH)
Time frame: infant 6 months old
Infant skin barrier function (sebum content)
Time frame: infant 24-48 hours
Infant skin barrier function (sebum content)
Time frame: infant 42 days old
Infant skin barrier function (sebum content)
Time frame: infant 6 months old
Infant skin barrier function (skin surface pH)
Time frame: infant 24-48 hours
Infant skin barrier function (skin surface pH)
Time frame: infant 42 days old
Infant skin barrier function (skin surface pH)
Time frame: infant 6 months old
prenatal exposure to Microplastics at early pregnancy
Time frame: 12-14 gestational weeks
prenatal exposure to Microplastics at mid pregnancy
Time frame: 22-26 gestational weeks
prenatal exposure to Microplastics at late pregnancy
Time frame: 34-36 gestational weeks
prenatal exposure to Microplastics at first trimester
Time frame: 12-14 gestational weeks
prenatal exposure to Microplastics at second trimester
Time frame: 22-26 gestational weeks
prenatal exposure to Microplastics at third trimester
Time frame: 34-36 gestational weeks
Microplastics in Umbilical cord whole blood
Time frame: at delivery.
Umbilical cord serum Microplastics
Time frame: at delivery.
Allergic rhinitis
Time frame: incidence of allergic rhinitis at the age of five.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 30428139Lowe 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.
- Background: PubMed 29343261Chen 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.
- Background: PubMed 24486970Okada 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.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Ye, MD,PhD principal investigator
Children's Hospital of Fudan University Shanghai, China, 201102
1 site in 1 country: see every site and its status.
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.