跳至主要内容
临床试验/NCT02292680
NCT02292680撤回不适用

Novel Biomarkers for Exposures in the Neonatal Intensive Care Unit

Icahn School of Medicine at Mount Sinai0 个研究点开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Chemical Concentration in deciduous teeth

研究概览

简要总结

This study aims to identify early life exposures to metals and chemicals by measuring the concentration of metals and organic compounds in shed primary teeth. The researchers will also investigate associations between the presence of these chemicals in teeth and children's social, emotional, and neuro-development.

详细描述

Since children begin shedding their primary teeth around age 6, the investigators will enroll children who will be turning 6 in the next two years. First, the investigators will follow up with the children's development by conducting a battery of non-invasive neurodevelopmental tests. Also, the parents will be asked to complete a questionnaire called the Child Behavior Checklist, which assesses behavioral problems. Then, each child's parent will be asked to send the research team 2-3 teeth that their child has shed, or to send teeth as they are shed over the next three years. Dr. Stroustrup's collaborator, Dr. Manish Arora, will perform a temporal analysis of chemical distribution for each tooth to determine each child's environmental exposures during the perinatal and neonatal periods.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 4-6 years of age in 2014 (six years of age by the end of 2016)
  • Cared for as a neonate in Mount Sinai's NICU

排除标准

  • Parent documented in Mount Sinai's database is no longer the legal guardian
  • Non-English-speaking parents

结局指标

主要结局

Chemical Concentration in deciduous teeth

时间窗: up to 5 years

Teeth will be analyzed by a dentist and researcher trained in laser ablation inductively coupled plasma mass spectroscopy technology

次要结局

  • Wechsler Preschool and Primary Scale of Intelligence(up to 3 years)
  • Child Behavior Checklist(up to 3 years)
  • Development Neuropsychological Assessment (NEPSY)(up to 3 years)

研究者

申办方类型
Other
责任方
Sponsor

相似试验

Childhood Measures of NICU-based Chemical Exposure | 临床试验