NCT03819192

Predicting EONS in PPROM Patients

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: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Jena University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• PPROM
• Early-Onset Neonatal Sepsis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	microbiome analysis	From all full age pregnant women with PPROM enrolled in this study vaginal smear samples will be taken at three time points: 1. directly after hospitalization 2. 5-7 days after beginning of antibiotic treatment 3. 24 h before birth The microbiome of the neonates of these women will be analysed out of pharyngeal and rectal swabs and umbilical cord blood taken directly after birth and additionally out of the first Meconium.
DIAGNOSTIC_TEST	Conventional cultures	For every sample taken for microbiome analysis, a conventional culture is taken as control.
DIAGNOSTIC_TEST	CAAP48 measurement	CAAP48 is an identified sepsis marker in adult patients. The samples are taken dependent on clinical monitoring to compare CAAP48 with established inflammation markers (CRP, IL-6, White blood cell count, Procalcitonin).

Timeline

• Start date: 2019-02-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2019-01-28
• Last updated: 2023-04-14

Locations

2 sites across 1 country: Germany