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临床试验/NCT03134768
NCT03134768已完成不适用

To Investigate the Immediate Effect of Birth on Immunological Parameters in Cord Blood, and Compare With Data of CS Born Infants Collected in the JULIUS SN Study

Danone Asia Pacific Holdings Pte, Ltd.0 个研究点目标入组 50 人开始时间: 2016年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
主要终点
Allergen Stimulated Cytokine Expression in the Supernatants of Cord Blood Mononuclear Cells (CBMC)

研究概览

简要总结

The purpose of the study is to understand the immediate effect of birth on immunological parameters in vaginally born cord blood.

详细描述

The main purpose of the study is to understand the immediate effect of birth on immunological parameters in vaginally born cord blood and also whether mode and duration of delivery has an influence on immune parameters in cord blood.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pregnant mothers undergoing normal vaginal delivery

排除标准

  • Use of non-steroidal anti-inflammatory drugs (NSAIDs) 2 weeks prior to birth
  • Antenatal antibiotics treatment (2 weeks prior to birth)
  • Diabetes mellitus requiring insulin treatment during pregnancy
  • Uncontrollable Hyperthyroidism during pregnancy

结局指标

主要结局

Allergen Stimulated Cytokine Expression in the Supernatants of Cord Blood Mononuclear Cells (CBMC)

时间窗: 1 year

Cellular response to allergen stimulation will be measured in supernatants of cultured cord blood mononuclear cells.

Cytokines Profile in Cord Blood Plasma

时间窗: 1 year

Following cytokines will be part of the profile: IL-6, IL-1, IL-2, IL-4, IL-5, IL-7, IL-8, IL-10, IL12p70, IL-13, IL-17, G-CSF, GM-CSF, IFNg, MCP-1(MCAF), MIP-1b, TNFa

Cord Blood Immunoglobulin Levels

时间窗: 1 year

Immunoglobulin levels will be measured in cord blood plasma

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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