Observational Study on Microplastics Exposure in Mothers and Infants

This observational study aims to understand how mothers and their exclusively breastfed infants in Baltimore, Maryland, are exposed to microplastics and nanoplastics (tiny plastic particles). Researchers want to find out what types of these plastics are present in breast milk, maternal blood, and infant stool samples. They will also explore if the amount of microplastics in breast milk is linked to the amount in infant stool, and which environmental or lifestyle factors might predict a mother's microplastic exposure. The study will also investigate if an infant's exposure to microplastics is connected to their birth weight and how they grow after birth. This study is for mothers who are 1 or 3 months postpartum and plan to exclusively breastfeed for at least 6 months.

Study design
This is an observational study with a planned enrollment of 40 participants. It will involve healthy, lactating women from Baltimore City and Baltimore County.
What's involved
You would provide samples of breast milk, venous blood, and infant stool at 1 or 3 months postpartum. Your height, weight, and other body measurements would be taken, along with your infant's weight, length, and skinfold thickness.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements for microplastic composition are taken at 1 or 3 months postpartum.

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NCT06107933

Developmental Impacts of Microplastics Exposure in Early Life

Recruiting
Not specifiedAges 18+Observational
Johns Hopkins Bloomberg School of Public Health
~40 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:Observational only

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Microplastic composition in maternal breastmilk
Measured over 1 or 3 months +/- 2 weeks postpartum
+5 more outcomes measured
Infant Development
Breast Feeding
Environmental Exposure
1 sites across 1 states
Maryland1
  • Tanya L Alderete, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins Bloomberg School of Public Health

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Microplastic composition in maternal breastmilk1 or 3 months +/- 2 weeks postpartum

    MNPs are measured using pyrolysis GC-HRMS using a Frontier Multi-Shot Pyrolyzer with Auto-Shot Sampler interfaced to a Trace 1310 gas chromatography system and Thermo Scientific Q Exactive GC Orbitrap GC-MS/MS.

  • Microplastic composition in maternal venous blood1 or 3 months +/- 2 weeks postpartum

    MNPs are measured using pyrolysis GC-HRMS using a Frontier Multi-Shot Pyrolyzer with Auto-Shot Sampler interfaced to a Trace 1310 gas chromatography system and Thermo Scientific Q Exactive GC Orbitrap GC-MS/MS.

  • Microplastic composition in infant stool1 or 3 months +/- 2 weeks postpartum

    MNPs are measured using pyrolysis GC-HRMS using a Frontier Multi-Shot Pyrolyzer with Auto-Shot Sampler interfaced to a Trace 1310 gas chromatography system and Thermo Scientific Q Exactive GC Orbitrap GC-MS/MS.

  • Infant weight1 or 3 months +/- 2 weeks postpartum

    Infant weight will be measured in duplicate on a digital scale accurate to the nearest 10 g

  • Infant length1 or 3 months +/- 2 weeks postpartum

    Infant length will be measured in duplicate to the nearest 0.1 cm using an Infantometer.

  • Infant skinfold thickness1 or 3 months +/- 2 weeks postpartum

    Infant skinfold thickness will be measured at four sites with Holtain skinfold callipers