- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Mersin, Tyrkiet (Türkiye), 33310
- Mersin University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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
|
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
|
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Primary outcome measure
Tidsramme: From July 2020 to July 2024
|
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
|
|
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.
Tidsramme: From July 2020 to July 2024
|
Term late onset sepsis diagnosis
|
From July 2020 to July 2024
|
|
Diagnostic efficacy of biomarkers in late neonatal sepsis
Tidsramme: Baseline and 3, 7-day serum biomarker
|
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.
|
Baseline and 3, 7-day serum biomarker
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
Andre undersøgelses-id-numre
- Mersin University Neonatology
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 Sen indsættende neonatal sepsis
-
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
-
Yale UniversityTrukket tilbageNeonatal tidligt opstået sepsis | Neonatal sent opstået sepsisForenede Stater
-
Franciscus GasthuisErasmus Medical CenterAfsluttetNeonatal infektion | Neonatal SEPSISHolland
-
prof. dr. Frans B. PlötzDutch Society of Pediatrics; Zorgevaluatie Nederland; Care4Neo; everywhereIMRekrutteringEOS | Tidlig opstået sepsis, neonatalHolland
-
Drugs for Neglected DiseasesUniversiteit Antwerpen; PENTA Foundation; St George's, University of LondonAfsluttetNeonatal SEPSISBangladesh, Uganda, Thailand, Sydafrika, Italien, Grækenland, Indien, Brasilien, Kina, Kenya, Vietnam
-
Assiut UniversityUkendt
-
Assiut UniversityUkendt
-
Sohag UniversityIkke rekrutterer endnu
-
Assiut UniversityUkendt
-
Shandong UniversityShandong Provincial HospitalRekrutteringTidlig opstået neonatal sepsisKina
Kliniske forsøg med serum biomarker
-
Assiut UniversityIkke rekrutterer endnu
-
Tanta UniversityAfsluttetLeverfibrose | Beta-thalassæmi majorEgypten
-
Pontificia Universidad Catolica de ChileHospital Dr Sotero del RioUkendtTørre øjne | Keratoconjunctivitis Sicca | Sygdomme i tåreapparatet | Konjunktivale sygdomme | Keratitis | Hornhindesygdomme | Sjøgrens syndromChile
-
Tanta UniversityRekrutteringRespiratory Distress Syndrome | Serum | Copeptin | Premature nyfødte | EndocanEgypten
-
ChinaNormAfsluttetAnsigtshud aldring og sløvhedKina
-
Assiut UniversityUkendtKardiotoksicitet | AluminiumfosfidforgiftningEgypten
-
BEIJING YUANBEN INFORMATION CONSULTING CO., LTDAfsluttetIngen fremspring | Intet åbent sår | Ingen alvorlig allergisk reaktion | Intet ar | Ingen tatovering | Ingen signifikant huddefektKina
-
Sohag UniversityIkke rekrutterer endnuThalassemia Majors (Beta-Thalassemi Major)
-
Laboratorios de Biologicos y Reactivos de México...Afsluttet
-
Victoria CollottaAktiv, ikke rekrutterende