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Chemical-Free Baby Products for Reducing Infant Chemical Exposure
N/A
Waitlist Available
Led By Linda G Kahn, PhD, MPH
Research Sponsored by NYU Langone Health
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 month 3
Awards & highlights
Study Summary
This trial will test if using phthalate- & bisphenol-free baby products can reduce exposure to these chemicals in infants during their first 3 months.
Who is the study for?
This trial is for pregnant individuals at least 37 weeks along, carrying a male fetus, and planning to breastfeed. They must be part of the NYU CHES study, over 18 years old, speak English or Spanish, and intend for their child's pediatric care to be at the Sunset Park Family Health Center.Check my eligibility
What is being tested?
The study tests if using phthalate- and bisphenol-free baby products versus conventional ones during an infant's early life can reduce harmful chemical exposure. Participants will use assigned products for three months with subsequent testing of breast milk and infant urine.See study design
What are the potential side effects?
Since this trial involves using everyday baby products that are free from certain chemicals rather than medications, there are no expected side effects related to typical drug interventions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to Intervention at Month 3
Secondary outcome measures
Concentration of Bisphenols in Breastmilk
Concentration of Bisphenols in Infant Urine
Concentration of Phthalate Metabolites in Breastmilk
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment2 Interventions
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Group II: Control GroupActive Control2 Interventions
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,751 Total Patients Enrolled
Linda G Kahn, PhD, MPHPrincipal InvestigatorNYU Langone Health
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Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for participants to sign up for this clinical trial?
"Clinicialtrials.gov states that this medical trial, which was initially posted on May 1st 2021 and recently modified on the 9th of May 2021, is not currently recruiting patients. Thankfully, there are other studies being conducted at present searching for participants to join them."
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