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Not yet recruiting NCT07572916

Tissue Doppler Echocardiographic Assessment of Cardiac Function in Neonatal Sepsis

Observational Neonatal Sepsis, Markers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cardiac troponin, and blood culture.
Who it may be relevant to
Registry conditions: Neonatal Sepsis, Markers. Basic parameters: 1 Day — 1 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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 \[6\].

Interventions

  • Diagnostic test cardiac troponin, and 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 pre

Primary outcome measures

  • assess myocardial function in neonates with sepsis using tissue doppler echocardiography. [Time frame: 1 year]
Secondary outcome measures (1)
  • To measure serum levels of sepsis markers (CBC,CRP,Blood culture) and cardiac troponin in neonatal sepsis. [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

This study includes 2 groups

  • sepsis group include neonate e 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

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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.

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Egypt · 1 center
  • Faculty of Medicine — Asyut

Identifiers

NCT: NCT07572916 · Echocardiogram in neonates

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗