- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07572916
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
- To assess myocardial function in neonates with sepsis using tissue doppler echocardiography.
- To assess sepsis induced cardiac dysfunction.
- To measure serum levels of sepsis markers (CBC,CRP,Blood culture) and cardiac troponin in neonatal sepsis.
- To analyze the correlation between echocardiographic parameters and serum biomarkers.
- To determine whether these echocardiographic techniques can serve as early predictors of cardiac involvement in neonatal sepsis.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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].
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Gehan Mohamed Gehan Mohamed Galal Shehata
- Numero di telefono: +201011087742
- Email: gehangalal@aun.edu.eg
Backup dei contatti dello studio
- Nome: Abd Ellatif A.Moiz Abd Ellatif M.Abdel Moiz
- Numero di telefono: 01005208016
- Email: a.m.abdelmoez@aun.edu.eg
Luoghi di studio
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Asyut, Egitto
- Faculty of medicine
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Contatto:
- Gehan Galal
- Numero di telefono: 01011087742
- Email: gehangalal2030@gmail.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
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
Descrizione
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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Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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sepsis group include neonate with sepsis (both preterm and term neonate)
confirmed to have neonatal sepsis by positive sepsis markers (CBC, CRP, Blood culture))
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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.
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- control group include healthy group admitted for weight gain or jaundice)
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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assess myocardial function in neonates with sepsis using tissue doppler echocardiography.
Lasso di tempo: 1 year
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To analyze the correlation between echocardiographic parameters and serum biomarkers.
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1 year
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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To measure serum levels of sepsis markers (CBC,CRP,Blood culture) and cardiac troponin in neonatal sepsis.
Lasso di tempo: 1 year
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determine whether these echocardiographic techniques can serve as early predictors of cardiac involvement in neonatal sepsis.
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1 year
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Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
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Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Infezioni
- Sepsi
- Sindrome da risposta infiammatoria sistemica
- Infiammazione
- Infante, neonato, malattie
- Malattie e anomalie congenite, ereditarie e neonatali
- Condizioni patologiche, segni e sintomi
- Sepsi neonatale
- Tecniche investigative
- Tecniche di laboratorio clinico
- Tecniche e procedure diagnostiche
- Diagnosi
- Tecniche microbiologiche
- Emocoltura
Altri numeri di identificazione dello studio
- Echocardiogram in neonates
Informazioni su farmaci e dispositivi, documenti di studio
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