Tissue Doppler Echocardiographic Assessment of Cardiac Function in Neonatal Sepsis

NCT07572916 | Not Yet Recruiting

• 1 other identifier: Echocardiogram in neonates
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neonatal Sepsis, Markers

Outcome Measures

Primary Outcomes (1)

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

  To analyze the correlation between echocardiographic parameters and serum biomarkers.

  1 year

Secondary Outcomes (1)

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

  1 year

Study Arms (2)

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

- control group include healthy group admitted for weight gain or jaundice)

Interventions

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.

sepsis group include neonate with sepsis (both preterm and term neonate)

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, Egypt

Location

Related Links

• Related Info

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Blood Culture

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Gehan Mohamed Gehan Mohamed Galal Shehata

CONTACT

+201011087742; gehangalal@aun.edu.eg

Abd Ellatif A.Moiz Abd Ellatif M.Abdel Moiz

CONTACT

01005208016; a.m.abdelmoez@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 7, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

EG (1)