Impact of microplastics on infant development and breastfeeding
Developmental Impacts of MicroPLastics Exposure in Early Life
This study is trying to see how microplastics in mothers' bodies might affect their babies' growth and development in the first few months after birth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Johns Hopkins Bloomberg School of Public Health Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06107933 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the exposure of micro- and nano-plastics (MNPs) in mothers and their infants living in Baltimore, Maryland, at 1 or 3 months postpartum. Participants will provide biological samples, including maternal blood, breastmilk, and infant stool, while completing questionnaires about their medical histories and lifestyle factors. The study will investigate the presence of MNPs in these samples and explore associations between maternal MNP levels and infant growth trajectories, as well as the environmental factors influencing maternal MNP burden.
Who should consider this trial
Good fit: Ideal candidates are mothers who are 1 or 3 months postpartum, exclusively breastfeeding, and have singleton births.
Not a fit: Patients with chronic conditions or disabilities that prevent participation, as well as those with major illnesses, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effects of microplastic exposure on infant health and development.
How similar studies have performed: While the study addresses a novel area of research regarding microplastics and infant health, similar studies on environmental exposures have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- East Baltimore Pediatric Inpatient and Outpatient Clinical Research Unit — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Tanya L Alderete, PhD — Johns Hopkins Bloomberg School of Public Health
- Study coordinator: Tanya L Alderete, PhD
- Email: tanya.alderete@colorado.edu
- Phone: 303-735-6249
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.