- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07635264
Late-Onset Neonatal Sepsis: A Case-Control Study (Sepsis)
Evaluation of Traditional Biomarkers and Novel Inflammatory Indices in the Diagnosis of Late-Onset Neonatal Sepsis: A Case-Control Study
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Mersin, Türkei (türkiye), 33310
- Mersin University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Term newborn
- Late-onset neonatal sepsis
Exclusion Criteria:
- Preterm newborn
- Major congenital anomaly
- Congenital metabolic disease
- Hemolytic anemia
- Hematological diseases
- Congenital leukemia
- Dyserythropoietic anemia
- Early-onset neonatal sepsis
Control group
- Neonatal jaundice (indirect hyperbilirubinemia)
- Transient neonatal tachypnea
- Early neonatal sepsis
Exclusion criteria Perinatal asphyxia, Meconium aspiration syndrome Polycythemia İntraventricular hemoragy Pneumothorax Hemolytic Anemia
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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Patient group 1 control group 2
The control group was selected to match the sepsis group as closely as possible (at a 1:1 ratio) in terms of demographic characteristics and taking gestational age into account
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that of diagnosis of sepsis, and on the third and seventh days after the commencement of antibiotic therapy.
SII was calculated using the formula (neutrophils×platelets)/lymphocytes, and SIAI using neutrophils×monocytes×platelets / lymphocytes
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control group and patient group
Neonates born before the 38th week of pregnancy, with major congenital anomaly or congenital metabolic disease, babies born to substance-dependent mothers, with hemolytic anemia or other hematological diseases (such as congenital leukemia, dyserythropoetic anemia, or severe hemolytic diseases), and babies diagnosed with immunodeficiency, with early-onset sepsis, with histories of surgery, or with deficient laboratory data were excluded. All babies diagnosed with LOS and meeting none of the exclusion criteria were enrolled and constituted the LOS cohort. In case of more than one LOS episode, only the first was included in the analysis. Babies with neonatal jaundice (indirect hyperbillurubinemia) of non-hemolytic causes that resolved with phototherapy alone, with transient neonatal tachypnea resolving within the first 24 hours and with no sepsis attack, and infants with non-infectious causes admitted to the NICU were included in the control group. Exclusion criteria for the control gr |
that of diagnosis of sepsis, and on the third and seventh days after the commencement of antibiotic therapy.
SII was calculated using the formula (neutrophils×platelets)/lymphocytes, and SIAI using neutrophils×monocytes×platelets / lymphocytes
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Primary outcome measure
Zeitfenster: From July 2020 to July 2024
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Immature granulocyte (IG) percentage, the neutrophil/lymphocyte ratio (NLR), CRP, PCT, SIAI, and SII values were recorded from retrospective file data on the first day, that of diagnosis of sepsis, and on the third and seventh days after the commencement of antibiotic therapy. SII was calculated using the formula (neutrophils×platelets)/lymphocytes, and SIAI using neutrophils×monocytes×platelets / lymphocytes. Diagnostic performance was assessed using receiver operating characteristic (ROC) curve analysis. This study aimed to evaluate the diagnostic performance of commonly used and novel inflammatory biomarkers, both individually and in combination, focusing on their temporal dynamics. The performance of diagnostic biomarkers (CRP, PCT, IG, SII, and SIAI) was evaluated using receiver operating characteristic (ROC) curve analysis. For each biomarker, the area under the curve (AUC), sensitivity, specificity, and positive and negative predictive values (PPV and NPV) were planned to be c |
From July 2020 to July 2024
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practical and effective biomarker combination consisting of widely available laboratory tests capable of being used in the diagnosis and monitoring of LOS in term neonates.
Zeitfenster: From July 2020 to July 2024
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Term late onset sepsis diagnosis
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From July 2020 to July 2024
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Diagnostic efficacy of biomarkers in late neonatal sepsis
Zeitfenster: Baseline and 3, 7-day serum biomarker
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LOS was defined as onset of sepsis symptoms after the 72nd hour (third day).
LOS resulted in respiratory symptoms (apnea, tachypnea, desaturation, and increasing mechanical ventilator support requirements), hemodynamic symptoms (bradycardia, skin color changes, decreased peripheral perfusion, hypotension and cardiovascular impairment, and inotropic therapy requirements), metabolic abnormalities (hypoglycemia, hyperglycemia, or metabolic acidosis abnormalities), body temperature irregularities (hypo or hyperthermia), feeding intolerance, and neurological symptoms (hypotonia, poor sucking, and low neurological activity) .
Sepsis was evaluated using complete blood count, CRP, PCT, and blood culture.
In line with our routine clinical protocol, specimens were collected from neonates with sepsis before the initiation of antibiotic therapy.
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Baseline and 3, 7-day serum biomarker
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Mersin University Neonatology
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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Klinische Studien zur Neugeborenen-Sepsis mit spätem Beginn
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Per Torp SangildOdense University Hospital; Aarhus University Hospital; Hvidovre University Hospital und andere MitarbeiterAbgeschlossenWachstum | Nekrotisierende Enterokolitis | Fütterungsunverträglichkeit | Late-Onset-SepsisDänemark
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