NCT06107933

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Oct 2023Jan 2027

Study Start

First participant enrolled

October 1, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

2.7 years

First QC Date

October 3, 2023

Last Update Submit

June 9, 2025

Conditions

Infant DevelopmentBreast FeedingEnvironmental Exposure

Keywords

microplasticbreastmilkinfant microplastic exposuregut microbiomefecal metabolome

Outcome Measures

Primary Outcomes (6)

  • 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 or 3 months +/- 2 weeks postpartum

  • 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 or 3 months +/- 2 weeks postpartum

  • 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 or 3 months +/- 2 weeks postpartum

  • Infant weight

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

    1 or 3 months +/- 2 weeks postpartum

  • Infant length

    Infant length will be measured in duplicate to the nearest 0.1 cm using an Infantometer.

    1 or 3 months +/- 2 weeks postpartum

  • Infant skinfold thickness

    Infant skinfold thickness will be measured at four sites with Holtain skinfold callipers

    1 or 3 months +/- 2 weeks postpartum

Secondary Outcomes (1)

  • Maternal stool microbiome composition

    1 or 3 months +/- 2 weeks postpartum

Study Arms (2)

City Mother-Infant Pairs

Mother-infant pairs living in a Baltimore City, Maryland zip code exposed to micro and nano plastics.

Other: Observational only

County Mother-Infant Pairs

Mother-infant pairs living in a Baltimore County, Maryland zip code exposed to micro and nano plastics.

Other: Observational only

Interventions

Observational onlyOTHER

Exposure to micro and nano plastics

City Mother-Infant PairsCounty Mother-Infant Pairs

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Baltimore Pediatric Inpatient and Outpatient Clinical Research Unit

Baltimore, Maryland, 21287, United States

RECRUITING

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Biospecimen

Retention: SAMPLES WITH DNA

maternal venous blood samples maternal breastmilk samples maternal stool samples infant stool samples

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Tanya L Alderete, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanya L Alderete, PhD

CONTACT

303-735-6249tanya.alderete@colorado.edu

Charlotte Haslett

CONTACT

7813256585chha5255@colorado.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2023

First Posted

October 30, 2023

Study Start

October 1, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

June 10, 2025

Record last verified: 2025-06

Locations

US(1)