The Correlation Between the n-6:n-3 Ratio and Inflammatory Markers in Small for Gestational Age (SGA) Infants Compared With Appropriate for Gestational Age (AGA) Infants
Numerous studies have recommended the use of n-3 PUFA supplementation during human pregnancy and lactation for the prevention of preterm birth, beneficial effects on fetal development, visual and cognitive development and other functional outcomes of the infants.
The aim of the present study is to assess the correlation between ratio of n-3:n-6 fatty acid and inflammation markers in SGA infants compared with appropriate for gestational age (AGA) infants. The investigators hypothesize that in SGA infants n-3 and n-6 fatty acid concentrations in cord blood will differ from those observed in AGA and might correlate with the level of circulating mediators.
研究概览
地位
干预/治疗
研究类型
注册 (预期的)
联系人和位置
学习地点
-
-
-
Tel-Aviv、以色列
- 招聘中
- Sourasky Medical Center (Ichilov)
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Mothers of SGA infants ( above 35 week of gestation)
- Mothers of term and near-term AGA infants
Exclusion Criteria:
- Maternal chronic diseases, smoking, diabetes, alcohol use, pregnancy-associated hypertension and pre-eclampsia
- Neonatal depression
- Congenital malformations
- Intrauterine infections
- Chromosomal aberrations
- Mothers interested in cord blood banking
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Blood test in Mothers of SGA Infants
In mothers of Small for Gestational Age (SGA) Infants, maternal and cord blood test will be performed
|
Blood will be drawn from mother's vein and from the cord to test for n-6:n-3 ratio and inflammatory markers: CRP, IL-6, TPO and TNF-alpha markers
|
|
Blood test in Mothers of AGA infants
In mothers of Appropriate for Gestational Age (AGA) Infants, maternal and cord blood test will be performed
|
Blood will be drawn from mother's vein and from the cord to test for n-6:n-3 ratio and inflammatory markers: CRP, IL-6, TPO and TNF-alpha markers
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cord blood analysis
大体时间:at time of delivery
|
Determination of the cord blood values of inflammatory markers (CRP, IL-6, TPO, TNF-alpha) and of the n-6:n-3 ratio
|
at time of delivery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Maternal blood analysis
大体时间:at time of delivery
|
Determination of the maternal blood values of inflammatory markers (CRP, IL-6, TPO, TNF-alpha) and of n-6:n-3 ratio
|
at time of delivery
|
合作者和调查者
调查人员
- 首席研究员:Dror Mandel, MD、Department of Neonatology, Lis Maternity Hospital, Tel Aviv Medical Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 0285-16-TLV-DM
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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