Hospital-Based Phthalate Exposure in Very Low Birth Weight Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Exposure to plasticizers
研究概览
简要总结
In this observational pilot project, the investigators plan to document duration and sources of exposure to plasticizers in infants born at birth weights less than 1500 grams. The investigators will examine the association between exposure to plasticizers and outcomes such as performance on a neurological screening tool, extrauterine growth, and thyroid function.
详细描述
High levels of exposure to certain plasticizers, specifically, phthalates and Bisphenol-A (BPA) have been shown to affect intelligence and behavior in school-age children, as well as to disrupt growth and some endocrine functions. Items used in the care of infants in the Neonatal Intensive Care Unit (NICU) contain phthalates and BPA. Babies admitted for long periods of time to the NICU, could be exposed to high levels of these potentially harmful plastics. In this study, the investigators are interested in documenting duration and sources of exposure to plasticizers during the NICU admission of infants born weighing less than 1500 grams. The investigators will examine the association between NICU exposure to plasticizers and performance on a neurological screening test that predicts future behavior, growth after birth, and the presence of any thyroid dysfunction.
The investigators plan to enroll 50 neonates in our study. The investigators will catalog all exposure to plasticizers during the infant's NICU admission and assign each baby a risk level of exposure. The investigators will then test each infant's performance on a neurological screening tool, measure growth from birth and assess whether or not each infant has thyroid dysfunction and correlate each outcome with exposure risk level. The investigators will also collect urine samples from each baby to store for possible future analysis.
The investigators hypothesize that neonates with higher levels of exposure will demonstrate worse performance on the neurological screening tool, poor growth, and abnormal thyroid function.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates born less than 1500 grams that are admitted to the Mount Sinai Hospital NICU
排除标准
- •Chromosomal abnormality or other genetic disorder
- •Diagnosis of hypoxic-ischemic encephalopathy
- •Inborn error of metabolism
- •Congenital renal disease
结局指标
主要结局
Exposure to plasticizers
时间窗: Length of stay in NICU which averages 8-10 weeks
Extent of exposure to plasticizers
Performance on neonatal neurological screening tool
时间窗: 34 weeks postconceptual age
次要结局
- Extrauterine growth(Weekly during NICU stay with average stay of 8-10 weeks)
- Thyroid dysfunction(4 weeks of age)
