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临床试验/NCT05175638
NCT05175638Unknown不适用

Macrophage Migration Inhibiting Factor, Enolase and Caspase-3 as Indicators of Neuronal Insult in Newborns of COVID-19 Positive Mothers.

Assiut University0 个研究点目标入组 50 人开始时间: 2022年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
the expression of specific CNS enzyme (enolase), proinflammatory cytokines MIF and apoptotic marker caspase-3 in the umbilical blood of infants delivered for Covid positive mothers.

研究概览

简要总结

The coronavirus disease (COVID- 19) is now a global pandemic that was first reported in China (Wuhan) in December of 2019. Multiple placental abnormalities including fetal and maternal vascular malperfusion have been described in pregnant women infected with (COVID- 19). To date, there are far fewer reports about the specific effects of (COVID- 19) in the newborns delivered for (COVID- 19) positive mothers.

详细描述

COVID-19 in pregnant women has important impacts on perinatal and neonatal outcomes. Authors reported positive COVID infection in neonates born to COVID-19 positive mother.

The finding of a recent study suggested that intrauterine or intrapartum transmission is possible and recommended for further investigation. Furthermore, reports showed newborns of COVID-19 positive mother that suffered from catastrophic sequelae of hypoxic ischemic encephalopathy (HIE). These events could be attributed to COVID-19 positive status of the mother.

Neuron specific enolase is a biomarker for neuronal injury and synaptic dysfunction and have been correlated with tissue damage in different experimental models. The increased serum levels of neuron specific enolase are associated with the clinical outcome in patients with anoxic encephalopathy. Neuron specific enolase can be a candidate for a diagnostic/prognostic biomarker for neuroinflammation in COVID-19.

Additionally, the cytokines are candidate biomarkers after hypoxic-ischemic injury. Macrophage migration inhibitory factor (MIF) is a multifunctional protein that has been identified as proinflammatory cytokine and activates the production of inflammatory cytokines such as tumor necrosis factor-α, interleukin-1β, interleukin-6, and interferon.

Macrophage migration inhibitory factor plays a central role in controlling the inflammatory and immune response, which may be of particular importance during the development of organ dysfunction in COVID-19 patients. Furthermore, it carries out the apoptosis of the cells. Significant increase of neuronal apoptosis and caspase-3 expression was demonstrated in the brain of neonatal mice exposed to hypoxic injury.

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
1 Day 至 2 Days(Child)
性别
All
接受健康志愿者

入选标准

  • The following inclusion criteria will be used (all necessary): Covid-19 positive mothers, term newborn (>37 completed gestational weeks), free from severe malformations. All infants will be examined generally, systemically and neurologically at birth for clinical assessment of HIE if present and for detection of outcome of these neonates.

排除标准

  • free from severe malformations

结局指标

主要结局

the expression of specific CNS enzyme (enolase), proinflammatory cytokines MIF and apoptotic marker caspase-3 in the umbilical blood of infants delivered for Covid positive mothers.

时间窗: one month

RNA extraction Reverse Transcription polymerase chain reaction (RT-PCR) analysis:

次要结局

未报告次要终点

研究者

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

Rasha Mohammed Ali

Principal investigator

Assiut University

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