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

This trial accepts healthy volunteers

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 population

The study will include 20 mother-infant pairs from Baltimore City and County. We will be studying lactating mothers at 1 or 3 months postpartum ±2 weeks.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Observational only

    Other intervention

    Exposure to micro and nano plastics

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: City Mother-Infant Pairs1 intervention
Group B: County Mother-Infant Pairs1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 or 3 months +/- 2 weeks postpartum
2

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.

Time frame
1 or 3 months +/- 2 weeks postpartum
3

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.

Time frame
1 or 3 months +/- 2 weeks postpartum
4

Infant weight

Infant weight will be measured in duplicate on a digital scale accurate to the nearest 10 g

Time frame
1 or 3 months +/- 2 weeks postpartum

Secondary outcomes

1

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.

Time frame
1 or 3 months +/- 2 weeks postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins Bloomberg School of Public Health

Lead sponsor

Emory University

Collaborator

Sonoma Technology, Inc.

Collaborator