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临床试验/NCT02557191
NCT02557191终止不适用

Biomarkers to Predict Neurodevelopmental Outcomes in Very Preterm Infants

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
1
主要终点
Brain white matter development

研究概览

简要总结

Approximately 2% of neonates in the US are born very preterm. Preterm births are associated with impaired cognitive, language and motor function, and increased risk for autism spectrum disorders. Epidemiological studies indicate a dose-response relationship between gestational age at delivery and cognitive impairments, with the most immature of newborns being the most susceptible to developmental delays. Sensitive and reproducible biomarkers of long-term neurocognitive impairments are currently lacking. The investigators seek to identify epigenetic markers that mediate the relationship between adverse prematurity-related exposures and neurocognitive impairments. The overarching hypothesis of this proposal is that DNA methylation profiles of CD34+ hematopoetic progenitor and stem cells from very preterm infants can be used as a risk-stratifying biomarker for predicting neurocognitive impairment in childhood.

研究设计

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

入排标准

年龄范围
1 Day 至 2 Days(Child)
性别
All
接受健康志愿者

入选标准

  • <32 weeks" gestation
  • Born at Weiler Division of Montefiore

排除标准

  • Intraventricular hemorrhage
  • Chromosomal abnormalities
  • Congenital viral conditions

结局指标

主要结局

Brain white matter development

时间窗: 38-42 weeks adjusted age

Brain MRI

次要结局

  • Neurodevelopment(18-24 months adjusted age)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mamta Fuloria

Associate Professor, Pediatrics

Montefiore Medical Center

研究点 (1)

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