Predicting EONS in PPROM Patients — PEONS  

Early-Onset Neonatal Sepsis Clinical Trial

Official title: Prediction of Early-Onset Neonatal Sepsis (EONS) in Pregnant Women With Preterm Premature Rupture of Membranes (PPROM) by Vaginal Microbiome Analysis - a Pilot Study

Status Recruiting

Clinical Trial Summary

An EONS occurred in nearly 14-22 % of the preterm infant of pregnant women with PPROM. To this day no risk prediction is established. The main aim of this pilot study is generating primary data with a focus on the vaginal microbiome to set-up a prospective, multi-centre trial investigating the role of the vaginal microbiome for future EONS risk prediction.

The planned PEONS pilot trial is subdivided in three Work packages:

1. Recruitment, sample collection and routine clinical diagnostics

2. Microbiome analysis by 16S rRNA

3. Microbiome/ Metagenome analysis by "Nanopore" (proof-of-principle) and will enroll women with a PPROM event hospitalized between 22+0 and 34+0 weeks of gestation and neonates with signs of EONS (Subgroup 1) and without signs of EONS (Subgroup 2).

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Early-Onset Neonatal Sepsis
• Neonatal Sepsis
• PPROM
• Sepsis

• NCT number: NCT03819192
• Study type: Observational
• Source: Jena University Hospital
• Contact: Ekkehard Schleußner, Prof. Dr.
• Phone: +49 3641
• Email: gabriele.schack@med.uni-jena.de
• Status: Recruiting
• Start date: February 1, 2019
• Completion date: December 31, 2023