Developmental Impacts of Microplastics Exposure in Early Life
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorJohns Hopkins Bloomberg School of Public Health
About this trial
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
Qualifiers
All gender expressions
Mothers at 1 or 3 months postpartum (± 2 weeks)
Intent to exclusively breastfeed for ≥ 6 months
Nulliparous and singleton births
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Observational only
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Johns Hopkins Bloomberg School of Public Health
Lead sponsor
Emory University
Collaborator
Sonoma Technology, Inc.
Collaborator
Source ClinicalTrials.gov