Developmental Impacts of Microplastics Exposure in Early Life

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins Bloomberg School of Public Health
Study ID
NCT06107933
Status
Recruiting
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Conditions

  • Breast Feeding
  • Environmental Exposure
  • Infant Development

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Observational only — OTHER
    Exposure to micro and nano plastics

Study Details

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 Dates

First listed
Oct 30, 2023
Start date
Oct 1, 2023
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: City Mother-Infant Pairs
    Mother-infant pairs living in a Baltimore City, Maryland zip code exposed to micro and nano plastics.
  • Arm: County Mother-Infant Pairs
    Mother-infant pairs living in a Baltimore County, Maryland zip code exposed to micro and nano plastics.

Primary Outcome Measure

Microplastic composition in maternal breastmilk [ Time Frame: 1 or 3 months +/- 2 weeks postpartum ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
East Baltimore Pediatric Inpatient and Outpatient Clinical Research UnitBaltimoreMaryland21287
Rachel Salamone, RN
[email protected]
410-614-6365

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By research site
East Baltimore Pediatric Inpatient and Outpatient Clinical Research Unit· Baltimore, MD

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