跳至主要内容
临床试验/NCT01420029
NCT01420029已完成不适用

Hospital-Based Phthalate Exposure in Very Low Birth Weight Neonates

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2011年8月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验