RECRUITING

Developmental Impacts of Microplastics Exposure in Early Life

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Developmental Impacts of MicroPLastics Exposure in Early Life

Quick Facts

Study Start:2023-10-01
Study Completion:2026-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06107933

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All gender expressions
  2. * Mothers at 1 or 3 months postpartum (± 2 weeks)
  3. * Intent to exclusively breastfeed for ≥ 6 months
  4. * Nulliparous and singleton births
  5. * Receiving only breast milk from the mother, with no formula supplementation
  1. * Physical, mental, or cognitive disability that prevents participation; current incarceration
  2. * 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)
  3. * Previously diagnosed with any major illness (e.g., intrauterine growth restriction, birth asphyxia, cancer) or eating disorder or previous gastric band surgery
  4. * 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.
  5. * Use of any breast pump except the Silicon Breast Pump for the 14 days prior to the clinical visit.
  6. * PHQ9 score greater than or equal to 10 indicating clinically relevant symptoms of moderate or worse depression
  7. * Infants who are intersex
  8. * Smoking, drug use (including marijuana use), or alcohol abuse

Contacts and Locations

Study Contact

Tanya L Alderete, PhD
CONTACT
303-735-6249
tanya.alderete@colorado.edu
Charlotte Haslett
CONTACT
7813256585
chha5255@colorado.edu

Principal Investigator

Tanya L Alderete, PhD
PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health

Study Locations (Sites)

East Baltimore Pediatric Inpatient and Outpatient Clinical Research Unit
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: University of Colorado, Boulder

  • Tanya L Alderete, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins Bloomberg School of Public Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-01
Study Completion Date2026-01-01

Study Record Updates

Study Start Date2023-10-01
Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

  • microplastic
  • breastmilk
  • infant microplastic exposure
  • gut microbiome
  • fecal metabolome

Additional Relevant MeSH Terms

  • Infant Development
  • Breast Feeding
  • Environmental Exposure