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Phthalates and bisphenols have been detected in a range of infant care products. This pilot study will test whether intervening on these sources of exposure during the critical period of minipuberty affects infants' body burden of phthalates and bisphenols. Investigators will recruit 10 participants from the ongoing NYU Children's Health and Development Study (CHES) cohort study who are >=37 weeks gestation, carrying a male fetus, and intending to breastfeed. Investigators will randomly assign them to use either conventional baby products or phthalate- and bisphenol-free baby products for the first three months of their children's lives. Toward the end of the intervention, investigators will collect maternal breast milk and infant urine, and assay samples for phthalate metabolite and bisphenol concentrations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 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. |
|
| Control Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phthalate- and Bisphenol-free Baby Products | Other | 3-month supply. Products include wipes and diaper cream. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Log Signal Intensity of Bisphenol A (BPA) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via non-targeted HPLC-MS/MS. The log signal intensity, an arbitrary unit, is a measurement of the signal strength of BPA in child urine; as the concentration of BPA increases, the signal intensity increases proportionally in a logarithmic fashion; higher values indicate greater infant exposure to bisphenol. | Month 3 |
| Log Signal Intensity of Bisphenol A (BPA) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via non-targeted HPLC-MS/MS. The log signal intensity, an arbitrary unit, is a measurement of the signal strength of BPA in child urine; as the concentration of BPA increases, the signal intensity increases proportionally in a logarithmic fashion; higher values indicate greater maternal exposure to bisphenol. | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Concentrations of Monomethyl Phthalate (mMP) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Month 3 |
| Mean Concentrations of Monomethyl Phthalate (mMP) in Maternal Urine Samples |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda G Kahn, PhD, MPH | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunset Park Family Health Center at NYU Langone - Second Avenue | Brooklyn | New York | 11220 | United States | ||
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: linda.kahn@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to linda.kahn@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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Infants were not considered enrolled participants for the purpose of this study; infant urine samples were submitted voluntarily by enrolled (mother) participants at home during follow-up. Participant information (participant flow, baseline characteristics) are thus not reported for infants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | 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. Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream. Cloth Diapers: Subscription to cloth diaper service. |
| FG001 | Control Group | 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. Conventional Disposable Diapers: 3-month supply. Conventional Baby Products: Products include wipes and diaper cream. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | 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. Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream. Cloth Diapers: Subscription to cloth diaper service. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Log Signal Intensity of Bisphenol A (BPA) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via non-targeted HPLC-MS/MS. The log signal intensity, an arbitrary unit, is a measurement of the signal strength of BPA in child urine; as the concentration of BPA increases, the signal intensity increases proportionally in a logarithmic fashion; higher values indicate greater infant exposure to bisphenol. | 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples | Posted | Mean | Standard Deviation | Log(Arbitrary Units) | Month 3 |
|
3 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | 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. Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream. Cloth Diapers: Subscription to cloth diaper service. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda G Kahn, PhD, MPH | NYU Langone Health | (917) 439-8069 | linda.kahn@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2023 | Mar 7, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C032279 | phthalic acid |
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| Cloth Diapers | Other | Subscription to cloth diaper service. |
|
| Conventional Disposable Diapers | Other | 3-month supply. |
|
| Conventional Baby Products | Other | Products include wipes and diaper cream. |
|
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
| Month 3 |
| Mean Concentrations of Monoethyl Phthalate (mEP) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Month 3 |
| Mean Concentrations of Monoethyl Phthalate (mEP) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Month 3 |
| Mean Concentrations of Phthalic Acid (PA) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Month 3 |
| Mean Concentrations of Phthalic Acid (PA) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Month 3 |
| Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Month 3 |
| Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Month 3 |
| Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Month 3 |
| Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Month 3 |
| Mean Concentrations of Monobutyl Phthalate (mBP) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Month 3 |
| Mean Concentrations of Monobutyl Phthalate (mBP) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Month 3 |
| Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Month 3 |
| Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Month 3 |
| Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Month 3 |
| Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Month 3 |
| Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Month 3 |
| Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Month 3 |
| Mean Concentrations of Bisphenol S (BPS) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Month 3 |
| Mean Concentrations of Bisphenol S (BPS) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Month 3 |
| Mean Concentrations of Mono-carboxy-isononyl Phthalate (mCINP) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Month 3 |
| Mean Concentrations of Ono-carboxy-isononyl Phthalate (mCINP) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Month 3 |
| Tisch Hospital |
| New York |
| New York |
| 10016 |
| United States |
| BG001 | Control Group | 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. Conventional Disposable Diapers: 3-month supply. Conventional Baby Products: Products include wipes and diaper cream. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control Group | 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. Conventional Disposable Diapers: 3-month supply. Conventional Baby Products: Products include wipes and diaper cream. |
|
|
| Primary | Log Signal Intensity of Bisphenol A (BPA) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via non-targeted HPLC-MS/MS. The log signal intensity, an arbitrary unit, is a measurement of the signal strength of BPA in child urine; as the concentration of BPA increases, the signal intensity increases proportionally in a logarithmic fashion; higher values indicate greater maternal exposure to bisphenol. | 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples | Posted | Mean | Standard Deviation | Log(Arbitrary Units) | Month 3 |
|
|
|
| Secondary | Mean Concentrations of Monomethyl Phthalate (mMP) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Only one intervention and one control sample was collected for child urine | Posted | Mean | Standard Deviation | microgram/gram creatinine | Month 3 |
|
|
|
| Secondary | Mean Concentrations of Monomethyl Phthalate (mMP) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | 3 out of 5 participants in the intervention group anf 2 out of 5 in the control group were analyzed as the rest did not provide samples | Posted | Mean | Standard Deviation | microgram/gram creatinine | Month 3 |
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| Secondary | Mean Concentrations of Monoethyl Phthalate (mEP) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Only one intervention and one control sample was collected for child urine | Posted | Mean | Standard Deviation | microgram/gram creatinine | Month 3 |
|
|
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| Secondary | Mean Concentrations of Monoethyl Phthalate (mEP) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples | Posted | Mean | Standard Deviation | microgram/gram creatinine | Month 3 |
|
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| Secondary | Mean Concentrations of Phthalic Acid (PA) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Only one intervention and one control sample was collected for child urine | Posted | Mean | Standard Deviation | microgram/gram creatinine | Month 3 |
|
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| Secondary | Mean Concentrations of Phthalic Acid (PA) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | 3 out of 5 participants in the intervention group anf 2 out of 5 in the control group were analyzed as the rest did not provide samples | Posted | Mean | Standard Deviation | microgram/gram creatinine | Month 3 |
|
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| Secondary | Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Only one intervention and one control sample was collected for child urine | Posted | Mean | Standard Deviation | microgram/gram creatinine | Month 3 |
|
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| Secondary | Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples | Posted | Mean | Standard Deviation | microgram/gram creatinine | Month 3 |
|
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| Secondary | Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | 3 out of 5 participants in the intervention group anf 2 out of 5 in the control group were analyzed as the rest did not provide samples | Posted | Mean | Standard Deviation | microgram/gram creatinine | Month 3 |
|
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| Secondary | Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples | Posted | Mean | Standard Deviation | microgram/gram creatinine | Month 3 |
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| Secondary | Mean Concentrations of Monobutyl Phthalate (mBP) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Only one intervention and one control sample was collected for child urine. | Posted | Mean | Standard Deviation | microgram/gram creatinine | Month 3 |
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| Secondary | Mean Concentrations of Monobutyl Phthalate (mBP) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples | Posted | Mean | Standard Deviation | microgram/gram creatinine | Month 3 |
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| Secondary | Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Only one intervention and one control sample was collected for child urine | Posted | Mean | Standard Deviation | microgram/gram creatinine | Month 3 |
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| Secondary | Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples | Posted | Mean | Standard Deviation | microgram/gram creatinine | Month 3 |
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| Secondary | Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Only one intervention and one control sample was collected for child urine | Posted | Mean | Standard Deviation | microgram/gram creatinine | Month 3 |
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| Secondary | Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples | Posted | Mean | Standard Deviation | microgram/gram creatinine | Month 3 |
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| Secondary | Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Only one intervention and one control sample was collected for child urine | Posted | Mean | Standard Deviation | microgram/gram creatinine | Month 3 |
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| Secondary | Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples | Posted | Mean | Standard Deviation | microgram/gram creatinine | Month 3 |
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| Secondary | Mean Concentrations of Bisphenol S (BPS) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Only one intervention and one control sample was collected for child urine | Posted | Mean | Standard Deviation | microgram/gram creatinine | Month 3 |
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| Secondary | Mean Concentrations of Bisphenol S (BPS) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | 2 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples | Posted | Mean | Standard Deviation | microgram/gram creatinine | Month 3 |
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| Secondary | Mean Concentrations of Mono-carboxy-isononyl Phthalate (mCINP) in Maternal Urine Samples | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | 2 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples | Posted | Mean | Standard Deviation | microgram/gram creatinine | Month 3 |
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| Secondary | Mean Concentrations of Ono-carboxy-isononyl Phthalate (mCINP) in Child Urine Samples | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. | Only one intervention and one control sample was collected for child urine | Posted | Mean | Standard Deviation | microgram/gram creatinine | Month 3 |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Control Group | 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. Conventional Disposable Diapers: 3-month supply. Conventional Baby Products: Products include wipes and diaper cream. | 0 | 5 | 0 | 5 | 0 | 5 |
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