Predicting EONS in PPROM Patients (PEONS)

Jena University Hospital

Status: Enrolling

Conditions: PPROM; Early-Onset Neonatal Sepsis

Treatments: Diagnostic Test: Conventional cultures; Diagnostic Test: CAAP48 measurement; Diagnostic Test: microbiome analysis

Study type: Observational

Funder types: Other

Identifiers

NCT03819192

KG-PEONS

Details and patient eligibility

About

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).

Enrollment: 150 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• full age pregnant woman with PPROM and their born preterm infants
• hospitalization between 22+0 and 34+0 weeks of gestation
• multipara possible

Exclusion criteria

• hospitalization with PPROM before limit of viability are reached
• intrauterine fetal death
• no study agreement
• not able to consent

Trial design

150 participants in 3 patient groups

neonates with signs of EONS

Treatment:

Diagnostic Test: microbiome analysis

Diagnostic Test: CAAP48 measurement

Diagnostic Test: Conventional cultures

neonates without signs of EONS

Treatment:

Diagnostic Test: microbiome analysis

Diagnostic Test: CAAP48 measurement

Diagnostic Test: Conventional cultures

pregnant women with PPROM

Treatment:

Diagnostic Test: microbiome analysis

Diagnostic Test: CAAP48 measurement

Diagnostic Test: Conventional cultures