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Late-Onset Neonatal Sepsis: A Case-Control Study (Sepsis)

4 juin 2026 mis à jour par: Aysen Orman, Mersin University

Evaluation of Traditional Biomarkers and Novel Inflammatory Indices in the Diagnosis of Late-Onset Neonatal Sepsis: A Case-Control Study

The diagnosis of late-onset sepsis in term neonates has been studied less than that of early-onset sepsis. Procalcitonin (PCT) and C-reactive protein (CRP) are commonly used biomarkers in the diagnosis of sepsis. However, their diagnostic advantage for late-onset sepsis (GNS) is debatable. Rapid and accurate diagnosis of late-onset infection in newborn infants remains a significant goal in clinical practice worldwide. Therefore, the accuracy of diagnostic tests needs to be improved. This study aimed to evaluate the effectiveness of serum biomarkers in the diagnosis and treatment monitoring of late neonatal sepsis (LOS) in term neonates.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Early diagnosis and detection of LOS are challenging due to its often nonspecific symptoms and the limited diagnostic efficacy of commonly used biomarkers. Therefore, a combined evaluation of clinical and laboratory findings is necessary. While initial assessment often includes nonspecific tests such as complete blood count and inflammatory markers, the most important test is a blood culture of at least 1 mL of blood before antibiotic administration.Although acute phase reactants such as C-reactive protein (CRP), procalcitonin (PCT), and various interleukins are used to support the diagnosis of sepsis in newborns, they are also elevated by other non-infectious inflammatory causes (fetal hypoxia, birth stress, RDS, MAS, IVH, surgery, and pneumothorax). Serum CRP could be a useful biomarker for LOS in newborn infants if it can be demonstrated to have acceptable levels of accuracy. Currently, the role of serum CRP in diagnostic algorithms for late-onset infection is largely varied in the absence of robust evidence to inform the development of guidelines or protocols. Further studies have shown that the immature/total neutrophil ratio and absolute neutrophil values are poor predictors of LOS. Due to age-specific, gestational age-dependent, and neonatal physiological changes in the early postpartum period, there is no consensus on the threshold value of serum PCT levels in bacterial infection.Common laboratory markers of infection, such as white blood cell count (WBC), immature neutrophil/total neutrophil ratio (IT ratio), hematological tests (thrombocytopenia), and acute phase reactants (CRP, PCT), do not have sufficient specificity and sensitivity to detect all infected newborns.Literature analysis has shown that, despite extensive research, the diagnosis and antibiotic treatment of neonatal sepsis cannot currently be determined based on a single biomarker. However, instead of searching for new biomarkers, testing combinations of two or more of the currently available biomarkers seems easier and more productive. The literature has focused primarily on the diagnosis of LOS in preterm neonates. Our current study differs from previous studies in that it evaluates the systemic inflammation aggregate index (SIAI) and systemic inflammation index (SII) values serially, in addition to classical biomarkers. Our aim is to identify a practical combination of commonly used laboratory tests that can evaluate the diagnosis and monitoring of term LOS when suspected.

Type d'étude

Observationnel

Inscription (Réel)

128

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

The study was conducted with two groups: term patients (38-42 weeks' gestation) and controls. 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

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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
Test diagnostique: serum biomarker
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
Test diagnostique: serum biomarker
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Primary outcome measure
Délai: 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.
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

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Parrainer

Mersin University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juillet 2020

Achèvement primaire (Réel)

1 juillet 2024

Achèvement de l'étude (Réel)

1 juillet 2025

Dates d'inscription aux études

Première soumission

21 avril 2026

Première soumission répondant aux critères de contrôle qualité

4 juin 2026

Première publication (Réel)

9 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Mersin University Neonatology

Plan pour les données individuelles des participants (IPD)

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NON

Description du régime IPD

Special sensitive population

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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