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临床试验/CTRI/2016/12/007536
CTRI/2016/12/007536已完成不适用

Feasibility and safety of Umbilical cord blood as a potential source for blood transfusion in neonates - Prospective cohort study.

Institute of Child Health and hospital for ChildrenDepartment of Neonatology1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年10月12日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
umbilical cord blood

研究概览

简要总结

Hypothesis of this study-It is feasible to separate and store packed red blood cell from umbilical cord blood and use it as a source for neonatal blood transfusion when required.primary purpose of this study to estimate the amount of umbilical cord blood that can be collected per neonate following delayed cord clamping across  different gestational ages,birth weight,mode of delivery and methods of collection.safety of the umbilical cord blood in terms of hematological,microbiological and biochemical quality on storage.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 1.00 Day(s)(—)
性别
All

入选标准

  • Mothers who consent for collection and storage of their Umbilical cord blood at the time of delivery.

排除标准

  • Mothers diagnosed with HIV/HBV/HCV/Malaria/Syphilis infection
  • Mothers who opt for stem cell storage from Umbilical cord blood.

结局指标

主要结局

umbilical cord blood

时间窗: 0, 7, 14, 21, 30 days

• Potassium (0, 7,14,21,30 days)

时间窗: 0, 7, 14, 21, 30 days

• Free Haemoglobin (0, 14, 28days)

时间窗: 0, 7, 14, 21, 30 days

• Cord blood culture (0,14 days)

时间窗: 0, 7, 14, 21, 30 days

1. Quantity of umbilical cord blood (ml) that can be collected per neonate across different gestational age, birth weight, mode of delivery and collection method 2. Change in Parameters of collected and stored

时间窗: 0, 7, 14, 21, 30 days

• Haematocrit (0, 7,14,21,30 days)

时间窗: 0, 7, 14, 21, 30 days

• pH (0, 7, 14, 21, 30 days)

时间窗: 0, 7, 14, 21, 30 days

次要结局

  • Quantity of packed RBC(ml) that can be(separated from the umbilical cord blood after)

研究者

发起方
Institute of Child Health and hospital for ChildrenDepartment of Neonatology
申办方类型
Government medical college

研究点 (1)

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