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临床试验/NCT04766541
NCT04766541Unknown不适用

THE ROLE OF CARDIAC MARKERS IN HYPOXIC ISCHEMIC ENCEPHALOPATHY IN LONG-TERM NEURODEVELOPMENTAL FOLLOW UP

Hacettepe University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年12月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Neurodevelopmental follow up Cardiac markers

研究概览

简要总结

In this study, the correlation of cardiac marker values (Troponin I, CK, CK-MB) measured before treatment with the long-term neurodevelopmental score of newborns diagnosed with perinatal asphyxia and treated with therapeutic hypothermia with a diagnosis of hypoxic ischemic encephalopathy (HIE) will be evaluated.

Physical examination, laboratory (especially cardiac markers), aEEG findings and diffusion MRI findings of babies who have been hospitalized in the neonatal intensive care unit between 2015-2020 due to respiratory distress and who have undergone perinatal asphyxia but have undergone therapeutic hypothermia treatment will be recorded from their files in the hospital system. The neurological evaluations and neurodevelopmental scores of the babies in the follow-up in the neonatal high risk follow-up clinic after discharge will be recorded from their files.

详细描述

With therapeutic hypothermia, it is aimed to reduce the temperature of brain structures and basal ganglia to 32- 34 degrees for 72 hours. The mechanism of action of hypothermia can be listed as decrease in cerebral metabolism, inhibition of edema, decrease in energy metabolism, decrease in cytotoxic amino acid and nitric oxide accumulation, inhibition of platelet activating factor and inflammatory cascade, suppression of free radical activity and prevention of cell death.

Perinatal hypoxia not only affects brain tissue, but also all organs. Therefore, the baby's respiratory system, blood gases, cardiac functions and liver functions are evaluated. Electrolyte, blood sugar and blood pressure are closely monitored due to the possibility of adrenal glands being affected. Since gastrointestinal injury is possible, nutrition is done extremely slowly and carefully. The useful markers in determining the neurological prognosis are the neurological findings of the patient as well as the defect in the aEEG monitoring.

Cardiac markers (CK, CK-MB, Troponin-I) have been shown to be a sensitive marker for asphyxia in term infants. Any interruption in the placental blood supply can cause the fetus to undergo hypoxic ischemia with the activation of the 'diving reflex' to protect the most vital organs. However, because myocardial tissue has insufficient reserves to tolerate hypoxia, myocardial injury may occur and an increase in serum troponin I, CK, CK-MB may occur. High levels of cardiac markers are an indicator of ongoing myocardial damage during HIE.

Diffusion MR imaging performed after hypothermia tries to see the damaged areas in the brain. Diffusion MRI and aEEG follow-up have been shown to be prognostic in the literature. Patients with hypothermia are followed up in our neonatal outpatient clinic and monitored in terms of growth and neurodevelopmental aspects.

In this study, the correlation of cardiac marker values (Troponin I, CK, CK-MB) measured before treatment with the long-term neurodevelopmental score of newborns diagnosed with perinatal asphyxia and treated with therapeutic hypothermia with a diagnosis of hypoxic ischemic encephalopathy (HIE) will be evaluated.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • Babies who have been hospitalized in the Neonatal Intensive Care Unit of Hacettepe University İhsan Doğramacı Children's Hospital, have received therapeutic hypothermia treatment for perinatal asphyxia and are discharged and have neurodevelopmental assessments during their follow-up will be taken.

排除标准

  • Babies with chromosomal abnormalities Major congenital anomaly (congenital heart disease, lung anomaly, congenital diaphragmatic hernia, spina bifida etc.) Babies with inherited metabolic diseases • Babies with congenital muscle disease-hypotonicity

结局指标

主要结局

Neurodevelopmental follow up Cardiac markers

时间窗: 12 months

In this study, the correlation of cardiac marker values (Troponin I, CK, CK-MB) measured before treatment with the long-term neurodevelopmental score of newborns diagnosed with perinatal asphyxia and treated with therapeutic hypothermia with a diagnosis of hypoxic ischemic encephalopathy (HIE) will be evaluated.

次要结局

  • Diffusion MRI and cardiac markers correlations(12 months)

研究者

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

Umit Ayse Tandircioglu

Medical Doctor

Hacettepe University

研究点 (1)

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