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Tissue Doppler Echocardiographic Assessment of Cardiac Function in Neonatal Sepsis

1. maj 2026 opdateret af: Gehan Mohamed Galal, Assiut University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Detaljeret beskrivelse

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].

Undersøgelsestype

Observationel

Tilmelding (Anslået)

80

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Gehan Mohamed Gehan Mohamed Galal Shehata
  • Telefonnummer: +201011087742
  • E-mail: gehangalal@aun.edu.eg

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

    -

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
sepsis group include neonate with sepsis (both preterm and term neonate)
confirmed to have neonatal sepsis by positive sepsis markers (CBC, CRP, 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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
assess myocardial function in neonates with sepsis using tissue doppler echocardiography.
Tidsramme: 1 year
To analyze the correlation between echocardiographic parameters and serum biomarkers.
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To measure serum levels of sepsis markers (CBC,CRP,Blood culture) and cardiac troponin in neonatal sepsis.
Tidsramme: 1 year
determine whether these echocardiographic techniques can serve as early predictors of cardiac involvement in neonatal sepsis.
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. maj 2028

Studieafslutning (Anslået)

1. maj 2029

Datoer for studieregistrering

Først indsendt

1. maj 2026

Først indsendt, der opfyldte QC-kriterier

1. maj 2026

Først opslået (Faktiske)

7. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Neonatal Sepsis, Markers

Kliniske forsøg med cardiac troponin, and blood culture

Abonner