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NCT Number: NCT07572916

Tissue Doppler Echocardiographic Assessment of Cardiac Function in Neonatal Sepsis

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.

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Key information

About this study

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].

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

cardiac troponin, and blood culture

Diagnostic Test

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.

Primary outcomes

  1. assess myocardial function in neonates with sepsis using tissue doppler echocardiography.

    Time frame: 1 year

    To analyze the correlation between echocardiographic parameters and serum biomarkers.

Secondary outcomes

  1. To measure serum levels of sepsis markers (CBC,CRP,Blood culture) and cardiac troponin in neonatal sepsis.

    Time frame: 1 year

    determine whether these echocardiographic techniques can serve as early predictors of cardiac involvement in neonatal sepsis.

Study contacts

Contact information is provided by the study sponsor or research team.

Abd Ellatif A.Moiz Abd Ellatif M.Abdel Moiz

CONTACT

[email protected]

01005208016

Gehan Mohamed Gehan Mohamed Galal Shehata

CONTACT

[email protected]

+201011087742

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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