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临床试验/NCT04057027
NCT04057027Unknown不适用

The Effect of Delayed Cord Clamping and Milking on the Amount of Endogenous Stem Cells In Preterm Infants

Kanuni Sultan Suleyman Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年9月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
2
主要终点
Concentration of Stem cells

研究概览

简要总结

Stem cell therapies have been promising therapies in neonatal morbidities such as bronchopulmonary dysplasia, intraventricular hemorrhage and hypoxic ischemic encephalopathy. Although researchers showed those effects by several mechanisms including paracrine effect, regenerative and restorative effects, there is no obvious recommendations for the type of stem cells, dosage or the route of administration the cells. The usage of exogenous stem cells can be difficult due to technical issues in preterm infants.

In the presence of these data, the amount of endogenous stem cells passing through the cord to the infant may show differences in terms of delayed cord clamping and milking. Therefore the aim of this prospective randomized study is to determine the quantity of the stem cells according to delayed cord clamping or cord milking. We also aimed to evaluate the association between the number of stem cells and neonatal morbidities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
— 至 30 Minutes(Child)
性别
All
接受健康志愿者

入选标准

  • Infants born under 32 weeks of gestation
  • Accepted to participate with informed consent
  • History of healthy pregnancy
  • Infants born and will be followed up at the study hospital

排除标准

  • Congenital abnormalities
  • Chromosomal abnormalities
  • Declined to participate

结局指标

主要结局

Concentration of Stem cells

时间窗: 6 months

Determining the quantity of endogenous stem cells transmitted through the umbilical cord to the infant after different types of cord clamping.

次要结局

  • Number of Participants with Neonatal Morbidities(6 months)

研究者

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

Merih Cetinkaya

Neonatologist

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (2)

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