Developmental Impacts of Microplastics Exposure in Early Life

Recruiting now

Conditions studied: Infant Development, Breast Feeding, Environmental Exposure

In brief

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

Key facts

Study ID

NCT06107933

Run by

Johns Hopkins Bloomberg School of Public Health

People needed

40

Starts

2023-10-01

Expected to finish

2027-01-01

Last updated by the study team

2026-06-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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), or 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 the postpartum period. Infant antibiotic use at any time during life or taking medications that could affect plastic exposure or the microbiome, such as medications administered via a plastic syringe.
• Use of any breast pump except the Silicon Breast Pump for the 14 days prior to the clinical visit.
• PHQ9 score greater than or equal to 10 indicating clinically relevant symptoms of moderate or worse depression
• Infants who are intersex
• Smoking, drug use (including marijuana use), or alcohol abuse

Where it is running

• East Baltimore Pediatric Inpatient and Outpatient Clinical Research Unit — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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