Tissue Doppler Echocardiographic Assessment of Cardiac Function in Neonatal Sepsis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neonatal Sepsis, Markers
• Intervention / Treatment: Diagnostic test: cardiac troponin, and blood culture

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].

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Gehan Mohamed Gehan Mohamed Galal Shehata; Phone Number: +201011087742; Email: gehangalal@aun.edu.eg
• Study Contact Backup: Name: Abd Ellatif A.Moiz Abd Ellatif M.Abdel Moiz; Phone Number: 01005208016; Email: a.m.abdelmoez@aun.edu.eg

Study Locations

• Egypt
  • Asyut, Egypt
    • Faculty of medicine
    • Contact: Gehan Galal; Phone Number: 01011087742; Email: gehangalal2030@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

   -

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
sepsis group include neonate with sepsis (both preterm and term neonate); confirmed to have neonatal sepsis by positive sepsis markers (CBC, CRP, Blood culture))	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 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess myocardial function in neonates with sepsis using tissue doppler echocardiography.	To analyze the correlation between echocardiographic parameters and serum biomarkers.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure serum levels of sepsis markers (CBC,CRP,Blood culture) and cardiac troponin in neonatal sepsis.	determine whether these echocardiographic techniques can serve as early predictors of cardiac involvement in neonatal sepsis.	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: May 1, 2026
• First Submitted That Met QC Criteria: May 1, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Neonatal Sepsis; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Microbiological Techniques; Blood Culture
• Other Study ID Numbers: Echocardiogram in neonates

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No