Actively Recruiting

Age: 18Years +
FEMALE
Healthy Volunteers
ID06107933

Developmental Impacts of MicroPLastics Exposure in Early Life

Led by Johns Hopkins Bloomberg School of Public Health · Updated on 2025-06-10

40

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

E

Emory University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating micro- and nano-plastic (MNP) exposures among mothers and their infants at 1 or 3 months postpartum to understand how these plastics may affect infant development and breastfeeding. The study focuses on identifying the types of MNPs present in maternal breastmilk, blood, and infant stool, and explores associations with infant growth, environmental factors, and lifestyle characteristics. This observational study recruits healthy, exclusively breastfeeding mother-infant pairs from diverse geographic areas in Baltimore, Maryland. Participants provide biological samples including maternal blood, breastmilk, and stool, as well as infant stool samples. Mothers use a silicone breast pump for milk collection, and special supplies are provided to avoid plastic contamination during stool collection at home or the clinical visit. Dietary information is gathered through questionnaires and recalls, and infants are weighed before and after feeding to estimate milk intake. Maternal and infant physical measurements such as height, weight, length, and skinfold thickness are recorded using standard equipment and methods. During the study, participants complete several questionnaires about medical history, lifestyle, and environmental exposures. Biological samples are analyzed for microplastic composition and microbiome sequencing, with advanced laboratory techniques used to assess microbial and metabolite profiles. Infant growth measurements and maternal health indicators, including blood pressure, are monitored. The study's main outcomes include microplastic presence in samples and infant growth metrics, with data collection and participant involvement spanning the postpartum period of 1 or 3 months plus or minus two weeks.

CONDITIONS

Brief Title

Developmental Impacts of Microplastics Exposure in Early Life

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • All gender expressions
  • Mothers at 1 or 3 months postpartum (± 2 weeks)
  • Intent to exclusively breastfeed for ≥ 6 months
  • Nulliparous and singleton births
  • Receiving only breast milk from the mother, with no formula supplementation
Not Eligible

You will not qualify if you...

  • Physical, mental, or cognitive disability that prevents participation; current incarceration
  • Chronic conditions in mother and/or infant (e.g., heart disease, cancer, autoimmune disease, diabetes, intestinal bowel syndrome/disease), conditions diagnosed during pregnancy (e.g., gestational diabetes), neurological or psychological conditions in mother and/or infant (e.g., epilepsy, bipolar disorder, postpartum depression)
  • Previously diagnosed with major illness or eating disorder or previous gastric band surgery
  • Maternal antibiotic use during pregnancy or postpartum; infant antibiotic use at any time or medications affecting plastic exposure or microbiome
  • Use of any breast pump except the Silicon Breast Pump for 14 days prior to the clinical visit
  • PHQ9 score ≥ 10 indicating moderate or worse depression
  • Infants who are intersex
  • Smoking, drug use (including marijuana), or alcohol abuse

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 2 weeks around the 1 or 3 months postpartum timepoint

Participants provide biological samples and complete assessments related to microplastics exposure and developmental measurements at 1 or 3 months postpartum (+/- 2 weeks). This includes home stool sample collection, breast milk expression, blood draws, dietary recalls, and infant feeding measurements.

1 clinical visit and home sample collections with phone assessments

Trial Site Locations

Total: 1 location

1

East Baltimore Pediatric Inpatient and Outpatient Clinical Research Unit

Baltimore, Maryland, United States, 21287

Actively Recruiting

Loading map...

Research Team

T

Tanya L Alderete, PhD

C

Charlotte Haslett

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Similar Trials

A Longitudinal Observational Study in Lactating Mothers and ...

Breast Feeding

Actively Recruiting

1 location

Noise and Ultrafine Particulate Matter Induced Cardiovascula...

Cardiovascular Diseases (CVD)

Actively Recruiting

2 locations

Building Food Sovereignty, Sustainability and Better Health ...

Environmental Exposure

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial