Atopic Dermatitis Clinical Trial
— PECCADOfficial title:
Prenatal Exposure to Emerging Contaminants and Offspring's Atopic Dermatitis (PECCAD)
Verified date | March 2024 |
Source | Children's Hospital of Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Active, not recruiting |
Enrollment | 456 |
Est. completion date | December 31, 2027 |
Est. primary completion date | April 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Children Hospital of Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Fudan University | Minhang Maternal and Children Health Care Hospital, School of Public Health,Fudan University |
China,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Umbilical cord serum Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) | Umbilical cord serum levels of PFDoDA, PFTrDA, PFHpDA, PFBS, PFPeS, PFHxS, PFOS, and PFDS | at delivery. | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Umbilical cord serum Organophosphate Flame Retardants (OPFRs) | Umbilical cord serum levels of PFDoDA, PFTrDA, PFHpDA, PFBS, PFPeS, PFHxS, PFOS, and PFDS | at delivery | |
Secondary | Infant skin barrier function (Transepidermal Water Loss, TEWL) | TEWL will be evaluated by the device of Multi Probe Adapter 4. | infant 24-48 hours | |
Secondary | Infant skin barrier function (Transepidermal Water Loss, TEWL) | TEWL will be evaluated by the device of Multi Probe Adapter 4. | infant 42 days old | |
Secondary | Infant skin barrier function (Transepidermal Water Loss, TEWL) | TEWL will be evaluated by the device of Multi Probe Adapter 4. | infant 6 months old | |
Secondary | Infant skin barrier function (Stratum corneum hydration, SCH) | SCH will be evaluated by the device of Multi Probe Adapter 4. | infant 24-48 hours | |
Secondary | Infant skin barrier function (Stratum corneum hydration, SCH) | SCH will be evaluated by the device of Multi Probe Adapter 4. | infant 42 days old | |
Secondary | Infant skin barrier function (Stratum corneum hydration, SCH) | SCH will be evaluated by the device of Multi Probe Adapter 4. | infant 6 months old | |
Secondary | Infant skin barrier function (sebum content) | Sebum content will be evaluated by the device of Multi Probe Adapter 4. | infant 24-48 hours | |
Secondary | Infant skin barrier function (sebum content) | Sebum content will be evaluated by the device of Multi Probe Adapter 4. | infant 42 days old | |
Secondary | Infant skin barrier function (sebum content) | Sebum content will be evaluated by the device of Multi Probe Adapter 4. | infant 6 months old | |
Secondary | Infant skin barrier function (skin surface pH) | Skin pH will be evaluated by the device of Multi Probe Adapter 4. | infant 24-48 hours | |
Secondary | Infant skin barrier function (skin surface pH) | Skin pH will be evaluated by the device of Multi Probe Adapter 4. | infant 42 days old | |
Secondary | Infant skin barrier function (skin surface pH) | Skin pH will be evaluated by the device of Multi Probe Adapter 4. | infant 6 months old | |
Secondary | prenatal exposure to Microplastics at early pregnancy | Maternal whole blood levels of Microplastics | 12-14 gestational weeks | |
Secondary | prenatal exposure to Microplastics at mid pregnancy | Maternal whole blood levels of Microplastics | 22-26 gestational weeks | |
Secondary | prenatal exposure to Microplastics at late pregnancy | Maternal whole blood levels of Microplastics | 34-36 gestational weeks | |
Secondary | prenatal exposure to Microplastics at first trimester | Maternal serum levels of Microplastics | 12-14 gestational weeks | |
Secondary | prenatal exposure to Microplastics at second trimester | Maternal serum levels of Microplastics | 22-26 gestational weeks | |
Secondary | prenatal exposure to Microplastics at third trimester | Maternal serum levels of Microplastics | 34-36 gestational weeks | |
Secondary | Microplastics in Umbilical cord whole blood | Umbilical cord whole blood levels of Microplastics | at delivery. | |
Secondary | Umbilical cord serum Microplastics | Umbilical cord serum levels of Microplastics | at delivery. | |
Secondary | Allergic rhinitis | An inquiry into the patient's medical history and electronic medical record | incidence of allergic rhinitis at the age of five. | |
Secondary | Asthma | An inquiry into the patient's medical history and electronic medical record | incidence of asthma at the age of five. | |
Secondary | Infantile hemangioma | Diagnosed by dermatologists | incidence of Infantile hemangioma at 1 year old |
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