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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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07572916
Enrollment
80
Registered
2026-05-07
Start date
2026-05-01
Completion date
2029-05-01
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Sepsis, Markers

Brief summary

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_TESTcardiac 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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 1 Months
Healthy volunteers
Yes

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. \-

Design outcomes

Primary

MeasureTime frameDescription
assess myocardial function in neonates with sepsis using tissue doppler echocardiography.1 yearTo analyze the correlation between echocardiographic parameters and serum biomarkers.

Secondary

MeasureTime frameDescription
To measure serum levels of sepsis markers (CBC,CRP,Blood culture) and cardiac troponin in neonatal sepsis.1 yeardetermine whether these echocardiographic techniques can serve as early predictors of cardiac involvement in neonatal sepsis.

Countries

Egypt

Contacts

CONTACTGehan Mohamed Gehan Mohamed Galal Shehata
gehangalal@aun.edu.eg+201011087742
CONTACTAbd Ellatif A.Moiz Abd Ellatif M.Abdel Moiz
a.m.abdelmoez@aun.edu.eg01005208016

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026