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Tissue Doppler Echocardiographic Assessment of Cardiac Function in Neonatal Sepsis

2026年5月1日 更新者:Gehan Mohamed Galal、Assiut University

Tissue Doppler Echocardiographic Assessment of Cardiac Function in Neonatal Sepsis and Correlation With Cardiac Troponin and Sepsis Biomarkers

  1. To assess myocardial function in neonates with sepsis using tissue doppler echocardiography.
  2. To assess sepsis induced cardiac dysfunction.
  3. To measure serum levels of sepsis markers (CBC,CRP,Blood culture) and cardiac troponin in neonatal sepsis.
  4. To analyze the correlation between echocardiographic parameters and serum biomarkers.
  5. To determine whether these echocardiographic techniques can serve as early predictors of cardiac involvement in neonatal sepsis.

研究概览

详细说明

Sepsis and septic shock are recognized as one of the most frequent causes of mortal complications in neonatal intensive care units worldwide. It has been observed that early-onset sepsis has become a serious and common issue among neonates, especially preterm infants (1) Cardiac dysfunction is a well-recognized complication of severe sepsis and septic shock and is a major contributor to morbidity and mortality in patients with sepsis [2].

The increasing use of echocardiographic techniques in neonatal intensive care units (NICU) has resulted in significant progress in the treatment of severely ill neonates in the last ten years, enabling more accurate and rapid assessment of the hemodynamic status of these fragile patients, in addition to introducing the possibility of individually tailored therapy for each patient. There is a current worldwide trend of intensive care pediatricians and neonatologists being trained to apply echocardiographic techniques, enabling the use of data obtained in everyday practice for clinical decision making [3].

Echocardiography emerges as a cornerstone in the non-invasive assessment of cardiac structure and function. Its capacity to be employed at the bedside offers immediate, real-time hemodynamic evaluation, making it an indispensable tool in neonatal intensive care. Through echocardiographic imaging, clinicians can delineate the cardiovascular profile of each neonate and tailor therapeutic approaches to address the specific underlying physio pathological abnormalities (4) Doppler echocardiography serves as another typical approach to assess cardiac structure and function. Sepsis-related CVD presents a <50% decrease in cardiac output or left ventricular ejection fraction (LVEF) (5) Tissue Doppler imaging is more sensitive in assessing diastolic function and is less dependent on preload and afterload than conventional Doppler methods [6].

研究类型

观察性的

注册 (估计的)

80

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Gehan Mohamed Gehan Mohamed Galal Shehata
  • 电话号码:+201011087742
  • 邮箱:gehangalal@aun.edu.eg

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

是的

取样方法

非概率样本

研究人群

neonate with sepsis (both preterm and term neonate confirmed to have neonatal sepsis by positive sepsis markers (CBC, CRP, Blood culture))

- control group include healthy group admitted for weight gain or jaundice) Babies on ventilators and non-invasive ventilation, septic shock are included in the study

描述

Inclusion Criteria:

This study includes 2 groups

  1. sepsis group include neonate e sepsis (both preterm and term neonate confirmed to have neonatal sepsis by positive sepsis markers (CBC, CRP, Blood culture))
  2. control group include healthy group admitted for weight gain or jaundice) Babies on ventilators and non-invasive ventilation, septic shock are included in the study

    -

    Exclusion Criteria:

    Infants with other comorbidities as congenital malformations, genetic syndromes, congenital heart diseases, infants of diabetic mothers, infants with hypoxic ischemic encephalopathy (HIE) or critical CHDs will be excluded from the study.

    -

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
sepsis group include neonate with sepsis (both preterm and term neonate)
confirmed to have neonatal sepsis by positive sepsis markers (CBC, CRP, Blood culture))
D) Echocardiographic examination: will be done according to the recommendation of the American Society of Echocardiography Integrated M-mode, two-dimensional (2-D) mode and pulsed and continuous wave Doppler will be used to estimate left ventricle (LV) internal dimensions including LV end diastolic dimension, LV ventricle end systolic dimension, ventricular septal thickness, posterior wall thickness, fractional shortening, mitral and tricuspid inflow velocities, and systolic pulmonary artery pressure. From the apical four-chamber planes, using pulsed wave tissue Doppler, the myocardial velocity curves of septal mitral valve annulus, lateral mitral valve annulus, and lateral tricuspid valve annulus will be recorded. The systolic wave (S) reflects the systolic function of either right or left ventricle. The early/atrial (E'/A') ratio of tricuspid and mitral valve annulus reflects the diastolic function of the right and left ventricle, respectively.
- control group include healthy group admitted for weight gain or jaundice)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
assess myocardial function in neonates with sepsis using tissue doppler echocardiography.
大体时间:1 year
To analyze the correlation between echocardiographic parameters and serum biomarkers.
1 year

次要结果测量

结果测量
措施说明
大体时间
To measure serum levels of sepsis markers (CBC,CRP,Blood culture) and cardiac troponin in neonatal sepsis.
大体时间:1 year
determine whether these echocardiographic techniques can serve as early predictors of cardiac involvement in neonatal sepsis.
1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

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有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月1日

初级完成 (估计的)

2028年5月1日

研究完成 (估计的)

2029年5月1日

研究注册日期

首次提交

2026年5月1日

首先提交符合 QC 标准的

2026年5月1日

首次发布 (实际的)

2026年5月7日

研究记录更新

最后更新发布 (实际的)

2026年5月7日

上次提交的符合 QC 标准的更新

2026年5月1日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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