NCT06107933 Developmental Impacts of Microplastics Exposure in Early Life
| NCT ID | NCT06107933 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins Bloomberg School of Public Health |
| Condition | Infant Development |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2023-10-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Tanya L Alderete, PhD
PRINCIPAL INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Frequently Asked Questions
Who can join the NCT06107933 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Infant Development. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06107933 currently recruiting?
Yes, NCT06107933 is actively recruiting participants. Contact the research team at tanya.alderete@colorado.edu for enrollment information.
Where is the NCT06107933 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06107933 clinical trial?
NCT06107933 is sponsored by Johns Hopkins Bloomberg School of Public Health. The principal investigator is Tanya L Alderete, PhD at Johns Hopkins Bloomberg School of Public Health. The trial plans to enroll 40 participants.