- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
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
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Gehan Mohamed Gehan Mohamed Galal Shehata
- Telefonnummer: +201011087742
- E-mail: gehangalal@aun.edu.eg
Undersøgelse Kontakt Backup
- Navn: Abd Ellatif A.Moiz Abd Ellatif M.Abdel Moiz
- Telefonnummer: 01005208016
- E-mail: a.m.abdelmoez@aun.edu.eg
Studiesteder
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Asyut, Egypten
- Faculty of medicine
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Kontakt:
- Gehan Galal
- Telefonnummer: 01011087742
- E-mail: gehangalal2030@gmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Prøveudtagningsmetode
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
- 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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Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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assess myocardial function in neonates with sepsis using tissue doppler echocardiography.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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To measure serum levels of sepsis markers (CBC,CRP,Blood culture) and cardiac troponin in neonatal sepsis.
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Infektioner
- Sepsis
- Systemisk inflammatorisk responssyndrom
- Betændelse
- Spædbarn, Nyfødt, Sygdomme
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Patologiske tilstande, tegn og symptomer
- Neonatal sepsis
- Undersøgelsesteknikker
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og procedurer
- Diagnose
- Mikrobiologiske teknikker
- Blodprøvekultur
Andre undersøgelses-id-numre
- Echocardiogram in neonates
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Neonatal Sepsis, Markers
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Jip GroenInBiomeRekrutteringMikrobiel kolonisering | Neonatal infektion | Neonatal sepsis, tidligt opstået | Mikrobiel sygdom | Klinisk sepsis | Kultur Negativ Neonatal Sepsis | Neonatal sepsis, sent opstået | Kultur Positiv Neonatal SepsisHolland
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Yale UniversityTrukket tilbageNeonatal tidligt opstået sepsis | Neonatal sent opstået sepsisForenede Stater
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Franciscus GasthuisErasmus Medical CenterAfsluttetNeonatal infektion | Neonatal SEPSISHolland
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prof. dr. Frans B. PlötzDutch Society of Pediatrics; Zorgevaluatie Nederland; Care4Neo; everywhereIMRekrutteringEOS | Tidlig opstået sepsis, neonatalHolland
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Drugs for Neglected DiseasesUniversiteit Antwerpen; PENTA Foundation; St George's, University of LondonAfsluttetNeonatal SEPSISBangladesh, Uganda, Thailand, Sydafrika, Italien, Grækenland, Indien, Brasilien, Kina, Kenya, Vietnam
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Assiut UniversityUkendt
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Assiut UniversityUkendt
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London School of Hygiene and Tropical MedicineAfsluttetNeonatal SEPSISBurkina Faso, Gambia
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Stephanie BjerrumRigshospitalet, Denmark; University of Copenhagen; University of Ghana; Korle-Bu...Afsluttet
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Drugs for Neglected DiseasesUniversity of Oxford; KEMRI-Wellcome Trust Collaborative Research ProgramAfsluttetNeonatal SEPSISKenya
Kliniske forsøg med cardiac troponin, and blood culture
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University of California, San DiegoTilmelding efter invitationVentrikulær fibrillation | Ventrikulær takykardi (VT) | For tidlig ventrikulær kontraktion (PVC)Forenede Stater
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Rigshospitalet, DenmarkRekrutteringAkut myeloid leukæmi (AML)Danmark