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临床试验/NCT03494738
NCT03494738已完成不适用

Development of an Epigenetic Biomarker for Prediction of Fetal Alcohol Spectrum Disorder

CAMC Health System2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2018年4月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
600
试验地点
2
主要终点
Epigenetic changes as biomarkers of prenatal alcohol exposure

研究概览

简要总结

The objective of the study is to validate epigenetic changes as biomarkers in a prospective sampling of newborn blood samples collected at birth (umbilical cord blood) and during routine screening (heel stick blood) in newborns concurrently tested for alcohol exposure levels by PEth blood spot testing.

详细描述

Fetal alcohol spectrum disorders (FASD) are a group of conditions that can occur in a person whose birth mother consumed alcohol during pregnancy. The effects can include physical problems and/or difficulties with behavior and learning. When clinicians identify FASD early, intervention approaches can minimize the potential impact and lessen or even prevent disabilities. Thus, objective markers for prenatal alcohol exposure are desired.

Using dried blood spots from the umbilical cord and a heel stick of newborns, this study will use Phosphatidylethanol (PEth), a novel biomarker for alcohol exposure, to identify and characterize infants' exposure to alcohol before birth. Additionally, the dried blood spots will used to validate the use of screening assays using epigenetic changes as markers for prenatal alcohol exposure. Epigenetic changes are heritable changes in DNA that affect DNA function but do not change DNA sequence. The use of PEth testing will allow for the correlation of prenatal alcohol exposure levels with epigenetic changes. Women will be consented prior to delivery for participation in this prospective study. The study will be conducted in collaboration with United States Drug Testing Laboratories, Inc. (USDTL).

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

  • Inclusion criteria
  • Women aged ≥ 18 years and currently pregnant at time of enrollment
  • Women who plan to and then deliver their infants at CAMC Women and Children's Hospital

排除标准

  • Women aged < 18 years
  • Women not pregnant
  • Women who do not plan to deliver or did not end up delivering their infants at CAMC Women and Children's Hospital
  • Inclusion criteria
  • Birth mother was consented prior to delivery
  • Live birth at CAMC Women and Children's Hospital
  • Exclusion criteria
  • Birth mother was NOT consented prior to delivery
  • Stillborn

研究组 & 干预措施

Newborn infants

Neonates born from consented women at the study hospital

结局指标

主要结局

Epigenetic changes as biomarkers of prenatal alcohol exposure

时间窗: 48 hours post birth

Validation of the epigenetic changes as biomarkers of newborn blood samples collected at birth (umbilical cord blood) and during routine screening (heel stick blood) in newborns concurrently tested for alcohol exposure levels by PEth blood spot testing.

次要结局

  • Optimal timing to obtain samples from neonates for prenatal alcohol detection(48 hours post birth)

研究者

发起方
CAMC Health System
申办方类型
Other
责任方
Sponsor

研究点 (2)

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