An Intervention to Reduce Phthalate and Bisphenol Exposure During the Critical Period of Minipuberty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Log Signal Intensity of Bisphenol A (BPA) in Child Urine Samples
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrolled in NYU CHES study at the NYULH-Brooklyn campus
- •18 years of age or older
- •At least 37 weeks gestation
- •Carrying a male singleton fetus
- •Intending to breastfeed
- •English or Spanish speaking
- •Intending for pediatric care for infant to occur at the Sunset Park Family Health Center at NYU Langone
排除标准
- •Not enrolled in NYU CHES study from the NYULH-Brooklyn campus
- •Under 37 weeks gestation
- •Carrying a female fetus
- •Carrying multiples
- •Not intending to breastfeed
- •Not comfortable communicating in English or Spanish
- •Not intending for pediatric care for infant to occur at NYULH Sunset Park Family Health Center
- •Under 18 years of age
研究组 & 干预措施
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.
干预措施: Phthalate- and Bisphenol-free Baby Products (Other)
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.
干预措施: Cloth Diapers (Other)
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.
干预措施: Conventional Disposable Diapers (Other)
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.
干预措施: Conventional Baby Products (Other)
结局指标
主要结局
Log Signal Intensity of Bisphenol A (BPA) in Child Urine Samples
时间窗: Month 3
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.
Log Signal Intensity of Bisphenol A (BPA) in Maternal Urine Samples
时间窗: Month 3
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.
次要结局
- Mean Concentrations of Monomethyl Phthalate (mMP) in Child Urine Samples(Month 3)
- Mean Concentrations of Monomethyl Phthalate (mMP) in Maternal Urine Samples(Month 3)
- Mean Concentrations of Monoethyl Phthalate (mEP) in Child Urine Samples(Month 3)
- Mean Concentrations of Monoethyl Phthalate (mEP) in Maternal Urine Samples(Month 3)
- Mean Concentrations of Phthalic Acid (PA) in Child Urine Samples(Month 3)
- Mean Concentrations of Phthalic Acid (PA) in Maternal Urine Samples(Month 3)
- Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Child Urine Samples(Month 3)
- Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Maternal Urine Samples(Month 3)
- Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Child Urine Samples(Month 3)
- Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Maternal Urine Samples(Month 3)
- Mean Concentrations of Monobutyl Phthalate (mBP) in Child Urine Samples(Month 3)
- Mean Concentrations of Monobutyl Phthalate (mBP) in Maternal Urine Samples(Month 3)
- Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Child Urine Samples(Month 3)
- Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Maternal Urine Samples(Month 3)
- Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Child Urine Samples(Month 3)
- Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Maternal Urine Samples(Month 3)
- Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Child Urine Samples(Month 3)
- Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Maternal Urine Samples(Month 3)
- Mean Concentrations of Bisphenol S (BPS) in Child Urine Samples(Month 3)
- Mean Concentrations of Bisphenol S (BPS) in Maternal Urine Samples(Month 3)
- Mean Concentrations of Mono-carboxy-isononyl Phthalate (mCINP) in Maternal Urine Samples(Month 3)
- Mean Concentrations of Ono-carboxy-isononyl Phthalate (mCINP) in Child Urine Samples(Month 3)