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Predicting EONS in PPROM Patients

NCT03819192 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2023-04-14

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Center of Fetal Surgery, University Hospital Halle Saale

    collaborator UNKNOWN

  • Section for Neonatology and Pediatric Intensive Care, University Hospital Halle Saale

    collaborator UNKNOWN

  • Jena University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03819192 on ClinicalTrials.gov