Prenatal Exposure to Emerging Contaminants and Children's Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— PECCAD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06316609
• Other study ID #: AD2016-2027
• Status: Active, not recruiting
• Start date: June 2016
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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.

Locations

Country	Name	City	State
China	Children Hospital of Fudan University	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	Minhang Maternal and Children Health Care Hospital, School of Public Health,Fudan University

Country where clinical trial is conducted

China, 

References & Publications (3)

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

Outcome

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