Status:
RECRUITING
Developmental Impacts of Microplastics Exposure in Early Life
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
Emory University
Sonoma Technology, Inc.
Conditions:
Infant Development
Breast Feeding
Eligibility:
FEMALE
18+ years
Brief Summary
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 Baltimo...
Detailed Description
The proposed pilot study will establish a new cohort of healthy, lactating women from Baltimore City and Baltimore County, Maryland. By recruiting women from these two regions, the investigators will ...
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
Key Trial Info
Start Date :
October 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06107933
Start Date
October 1 2023
End Date
January 1 2027
Last Update
June 10 2025
Active Locations (1)
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1
East Baltimore Pediatric Inpatient and Outpatient Clinical Research Unit
Baltimore, Maryland, United States, 21287