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临床试验/NCT06851390
NCT06851390已完成不适用

Inflammation and Cerebral Oxygenation in Preterm Newborns Following Fetal Red Blood Cell Transfusion Compared to Adult Red Blood Cell Transfusion

Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年5月14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
75
试验地点
1
主要终点
measure of pro-inflammatory cytokine levels (IL-1β, IL-8, TNF-α) andMCP-1, MIF, s-ICAM levelscirculating in preterm newborns before transfusion and two hours after transfusion

研究概览

简要总结

Among diseases associated with premature birth, retinopathy of prematurity (ROP) is one of the most important causes of childhood blindness. ROP develops in the immature retina as a consequence of prolonged exposure to hyperoxia. A body of evidence suggests a connection between ROP and the number of red blood cell (RBC) transfusions. Moreover, in newborns receiving repeated transfusions, fetal hemoglobin (HbF) progressively declines. Our NICU participate to the BORN (umBilical blOod to tRansfuse preterm Neonates) trial, a double-blind, multi-center, randomized controlled trial with the aim of evaluating if preterm newborns randomized to receive cord blood (CB)-transfusions have a lower incidence of ROP, compared to newborns transfused with adult RBC cells. In the context of BORN trial, with this ancillary INCONTRA study, the investigators aim to explore the inflammatory burden, potentially impacting on development of the preterm newborn comorbidities, following CB-RBC transfusions, compared to adult RBC transfusions. to estimate the change in pro-inflammatory cytokine (IL-1β, IL-8, TNF-α) and MCP-1, MIF, s-ICAM levels levels circulating in preterm newborns before and after transfusion, Moreover, we want to monitor cerebral oxygenation and oxygenation delivery to the brain during and after the transfusion of the two different RBC products. Moreover, the investigators aim to monitor cerebral oxygenation and oxygenation delivery to the brain during and after the transfusion of the two different RBC products.

研究设计

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

入排标准

年龄范围
23 Weeks 至 28 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

measure of pro-inflammatory cytokine levels (IL-1β, IL-8, TNF-α) andMCP-1, MIF, s-ICAM levelscirculating in preterm newborns before transfusion and two hours after transfusion

时间窗: During the first 4 months of life.

次要结局

  • trend of cerebral rStO2, measured by near infrared spectroscopy (NIRS)(In the time of time of transfusion)

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefano Ghirardello

MD, Chief of Neonatal Unit and Neonatal Intensive care Unit

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (1)

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