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Boulder Mother-Infant Pairs for Environmental Exposures (DIMPLE Trial)

N/A
Recruiting
Led By Tanya L Alderete, PhD
Research Sponsored by University of Colorado, Boulder
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month +/- 2 weeks postpartum
Awards & highlights

DIMPLE Trial 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 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

Eligible Conditions
  • Environmental Exposures
  • Infant Development
  • Breastfeeding

DIMPLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month +/- 2 weeks postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month +/- 2 weeks postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Infant length
Infant skinfold thickness
Infant weight
+3 more
Secondary outcome measures
Maternal stool microbiome composition

DIMPLE Trial Design

2Treatment groups
Experimental Treatment
Group I: Denver Mother-Infant PairsExperimental Treatment1 Intervention
Mother-infant pairs living in a Denver, Colorado zipcode
Group II: Boulder Mother-Infant PairsExperimental Treatment1 Intervention
Mother-infant pairs living in a Boulder, Colorado zipcode

Find a Location

Who is running the clinical trial?

Sonoma Technology, Inc.UNKNOWN
University of Colorado, BoulderLead Sponsor
119 Previous Clinical Trials
29,154 Total Patients Enrolled
Emory UniversityOTHER
1,636 Previous Clinical Trials
2,560,533 Total Patients Enrolled
1 Trials studying Environmental Exposures
2,370 Patients Enrolled for Environmental Exposures

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~21 spots leftby Jan 2025