Actively Recruiting

Age: 18Years +
FEMALE
Healthy Volunteers
NCT06107933

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

169 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

The goal of this observational study is to characterize and evaluate micro- and nano-plastic (MNP) exposures among mothers and infants in mother-infant dyads 1 or 3 months postpartum living in Baltimore, Maryland. The main questions it aims to answer are: * What MNPs are present in breastmilk and maternal blood samples and in their infants stool sample? * Are there associations between amount of maternal MNPs in breast milk and mass of MNP particles in infant stool? * Which environmental and lifestyle factors are most predictive of maternal MNP burden? * Is infant exposure to MNPs associated with birth weight and postnatal growth trajectories? Participants will: * Complete several questionnaires assessing medical histories, lifestyle factors, environmental exposures, eating behaviors, etc. * Provide biological specimens including: maternal blood, stool, and breastmilk; infant stool * Clinical visit to have anthropometric measures documented including maternal height and weight, infant weight, length, and skin-fold thickness

CONDITIONS

Official 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 65 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 for the first time during pregnancy (e.g., gestational diabetes)
  • Neurological conditions in mother and/or infant (e.g., epilepsy, seizures)
  • Psychological conditions in mother and/or infant (e.g., bipolar disorder)
  • Neurological/psychological conditions diagnosed in mother during or immediately after pregnancy (e.g., postpartum depression)
  • Previously diagnosed with any major illness (e.g., intrauterine growth restriction, birth asphyxia, cancer) 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 the 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

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Trial Site Locations

Total: 1 location

1

East Baltimore Pediatric Inpatient and Outpatient Clinical Research Unit

Baltimore, Maryland, United States, 21287

Actively Recruiting

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Research Team

T

Tanya L Alderete, PhD

CONTACT

C

Charlotte Haslett

CONTACT

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

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