Infant Development Clinical Trial
— DIMPLEOfficial title:
Developmental Impacts of MicroPLastics Exposure in Early Life
NCT number | NCT06107933 |
Other study ID # | 23-0314 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2023 |
Est. completion date | January 1, 2026 |
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 one-month postpartum living in Denver and Boulder, Colorado. 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
Status | Recruiting |
Enrollment | 40 |
Est. completion date | January 1, 2026 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All gender expressions - Mothers at 1-month postpartum (± 2 weeks) - Intent to exclusively breastfeed for = 6 months - Nulliparous and singleton births 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 - Antibiotic use during pregnancy or within 1 month of delivery, smoking, drug use, or alcohol abuse - Living outside the study region during the pregnancy or postpartum period - Use of plastic storage bags to store breastmilk - Center for Epidemiology Studies Depression (CESD)-10 score greater than or equal to 10 indicating clinically relevant symptoms of depression (=10) - Infants who are intersex |
Country | Name | City | State |
---|---|---|---|
United States | Clinical Translational Research Center CU Boulder | Boulder | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Boulder | Emory University, Sonoma Technology, Inc. |
United States,
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* Note: There are 106 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Microplastic composition in maternal breastmilk | MNPs are measured using pyrolysis GC-HRMS using a Frontier Multi-Shot Pyrolyzer with Auto-Shot Sampler interfaced to a Trace 1310 gas chromatography system and Thermo Scientific Q Exactive GC Orbitrap GC-MS/MS. | 1 month +/- 2 weeks postpartum | |
Primary | Microplastic composition in maternal venous blood | MNPs are measured using pyrolysis GC-HRMS using a Frontier Multi-Shot Pyrolyzer with Auto-Shot Sampler interfaced to a Trace 1310 gas chromatography system and Thermo Scientific Q Exactive GC Orbitrap GC-MS/MS. | 1 month +/- 2 weeks postpartum | |
Primary | Microplastic composition in infant stool | MNPs are measured using pyrolysis GC-HRMS using a Frontier Multi-Shot Pyrolyzer with Auto-Shot Sampler interfaced to a Trace 1310 gas chromatography system and Thermo Scientific Q Exactive GC Orbitrap GC-MS/MS. | 1 month +/- 2 weeks postpartum | |
Primary | Infant weight | Infant weight will be measured in duplicate on a digital scale accurate to the nearest 10 g | 1 month +/- 2 weeks postpartum | |
Primary | Infant length | Infant length will be measured in duplicate to the nearest 0.1 cm using an Infantometer. | 1 month +/- 2 weeks postpartum | |
Primary | Infant skinfold thickness | Infant skinfold thickness will be measured at four sites with Holtain skinfold callipers | 1 month +/- 2 weeks postpartum | |
Secondary | Maternal stool microbiome composition | Maternal stool will be stored in cryovials at -80C for future metagenomic sequencing to analyze the composition of the gut microbiome. | 1 month +/- 2 weeks postpartum |
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