Extracellular Vesicle Analysis in Neonates at Risk for Early Onset Sepsis

Extracellular Vesicle Analysis in Neonates at Risk for Early Onset Sepsis - EVANEOS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035394

Enrollment

100

Registered

2025-04-01

Start date

2024-01-01

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

P36

Interventions

Group 1: Newborns with clinical sepsis and a positive pathogen detection: This group includes newborns diagnosed with clinical sepsis, confirmed by the detection of a pathogen in the blood culture. I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: “Infection Group” Pregnant women and newborns with risk factors for early neonatal infection or Early Onset Sepsis (EOS). These include: -Clinical chorioamnionitis, characterized by one or more of the following findings: maternal fever during labor, leukocytosis, uterine tenderness, foul-smelling vaginal discharge, and/or fetal tachycardia. -Prolonged rupture of membranes (>18 hours) before delivery. -Colonization of the mother with Group B streptococci (GBS) "Control Group" For comparison purposes, a group of pregnant women and newborns without clinical signs or laboratory findings for EOS will also be included.

Exclusion criteria

Exclusion criteria: Exclusion Criteria -Syndromic conditions in the newborn (e.g., Trisomy 13, 18, 21) -Severe congenital anomalies in the newborn (e.g., complex heart defects) -Perinatal asphyxia (arterial umbilical cord pH < 7.1) -Preeclampsia/HELLP syndrome -Suspected or confirmed TORCH infection -Coagulation disorders/hematological conditions in the pregnant woman -Malignancies in the pregnant woman

Design outcomes

Primary

Measure	Time frame
The aim of this research project is to prospectively isolate EVs from the umbilical cord blood of newborns with risk factors for early-onset sepsis (EOS) and to characterize their composition and features. Four study groups are differentiated based on clinical outcomes: 1) newborns with clinical sepsis and a positive pathogen detection, 2) newborns with clinical sepsis without pathogen detection, 3) newborns with suspected infection (not meeting sepsis criteria), and 4) newborns without infection. In parallel, EVs from maternal blood are also analyzed. These investigations aim to identify potential differences in EVs depending on the infection status of newborns and pregnant women, in order to evaluate their potential as biomarkers and therapeutic targets.	—

Measure

Time frame

The aim of this research project is to prospectively isolate EVs from the umbilical cord blood of newborns with risk factors for early-onset sepsis (EOS) and to characterize their composition and features. Four study groups are differentiated based on clinical outcomes: 1) newborns with clinical sepsis and a positive pathogen detection, 2) newborns with clinical sepsis without pathogen detection, 3) newborns with suspected infection (not meeting sepsis criteria), and 4) newborns without infection. In parallel, EVs from maternal blood are also analyzed. These investigations aim to identify potential differences in EVs depending on the infection status of newborns and pregnant women, in order to evaluate their potential as biomarkers and therapeutic targets.

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Secondary

Measure	Time frame
In addition, to better understand potential infection pathways and disease mechanisms, the gut microbiome of neonates and their mothers will be characterized, and pathogenic bacterial strains (Streptococci, Staphylococci, Enterococci) as well as protective strains (Lactobacilli) will be isolated. For children requiring antibiotic therapy, a blood sample (0.5 ml of whole blood) will be collected alongside the routine blood culture prior to the start of therapy for sequencing of pathogenic organisms (comparison with the gut microbiome).	—

Measure

Time frame

In addition, to better understand potential infection pathways and disease mechanisms, the gut microbiome of neonates and their mothers will be characterized, and pathogenic bacterial strains (Streptococci, Staphylococci, Enterococci) as well as protective strains (Lactobacilli) will be isolated. For children requiring antibiotic therapy, a blood sample (0.5 ml of whole blood) will be collected alongside the routine blood culture prior to the start of therapy for sequencing of pathogenic organisms (comparison with the gut microbiome).

—

Countries

Germany

Contacts

Public ContactClaudia Nußbaum

Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

claudia.nussbaum@med.uni-muenchen.de+49 89 4400 32201

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026