跳至主要内容
临床试验/NCT02779452
NCT02779452已完成不适用

Does Brain Functions Depend on Omega 3 Transferred to the Fetus During the Intra Uterine Life ?

Université de Sherbrooke0 个研究点目标入组 46 人开始时间: 2013年12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
46
主要终点
Change in neurodevelopment

研究概览

简要总结

The purpose of this study is to evaluate the feasibility of using a quantitative EEG method to evaluate neurodevelopment in newborns and to evaluate whether subtle neurodevelopmental deficits can be detected in newborns from mothers with gestational diabetes mellitus (GDM) compared to control newborns.

The second purpose of this study is to determine whether cord blood concentration in docosahexaenoic acid (DHA), an omega-3 fatty acid, is similar in neonates of well-controlled mothers with gestational diabetes mellitus (GDM) compared to control mothers, and to evaluate whether this contributes to neonates neurodevelopment status.

详细描述

Maternal weight is measured close to delivery and BMI is calculated. Birth weight, length, head circumference, Apgar score and glycaemia are recorded at birth. An EEG are performed on the newborn within 48 hrs after birth.A maternal blood sample is collected at admission to measure maternal glycated hemoglobin (A1C). Cord blood samples are collected in the umbilical vein after delivery.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • singleton pregnancy
  • aged between 18 and 40 years

排除标准

  • illicit drug consumption,
  • omega-3/6 consumption,
  • liver or renal disease,
  • any medical conditions affecting glucose/lipid metabolism.

结局指标

主要结局

Change in neurodevelopment

时间窗: At birth

Evaluate change in neurodevelopment with GDM

次要结局

  • Change in DHA level in cord blood(At birth)

研究者

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

Mélanie Plourde

PhD

Université de Sherbrooke

相似试验