Prenatal Exposure to Emerging Contaminants and Children's Atopic Dermatitis

NCT06316609 | Active Not Recruiting

• 1 other identifier: AD2016-2027
• Study Type: observational
• Target: 456
• Locations: 1 country
• Sites: 1

Brief 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.

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; Cohort; Birth

Outcome Measures

Primary Outcomes (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.

  at 1 year old

Secondary Outcomes (42)

• atopic dermatitis

  incidence of AD during 6 months after birth

• atopic dermatitis

  incidence of AD at the age of two.

• atopic dermatitis

  incidence of AD at the age of five.

• prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at early pregnancy

  12-14 gestational weeks

• prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at mid pregnancy

  22-26 gestational weeks

Study Arms (2)

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.

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.

Other: Gestational Exposure to Emerging Contaminants (ECs)

Interventions

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.

Also known as: Gestational Exposure to Contaminants of Emerging Concern (CECs), Gestational Exposure to Contaminants of Emerging pollutants

participants from birth cohort with AD; participants from birth cohort without AD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Mother plans to proceed prenatal care and delivery in Minhang Maternal and Children Health Care Hospital
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• Minhang Maternal and Children Health Care Hospital: collaborator
• School of Public Health，Fudan University: collaborator

Study Sites (1)

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (3)

• 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.

  PMID: 30428139 BACKGROUND

• 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.

  PMID: 29343261 BACKGROUND

• 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.

  PMID: 24486970 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

All serum, whole blood, and DNA samples are stored in a -80°C freezer.

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

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

Study Officials

• Ying Ye, MD,PhD

  Children's Hospital of Fudan University Shanghai, China, 201102

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 18, 2024
• Study Start: June 1, 2016
• Primary Completion: April 30, 2018
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)