Early-Onset Neonatal Sepsis, PPROM
Conditions
Brief 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).
Interventions
DIAGNOSTIC_TESTmicrobiome 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_TESTConventional cultures
For every sample taken for microbiome analysis, a conventional culture is taken as control.
DIAGNOSTIC_TESTCAAP48 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
Center of Fetal Surgery, University Hospital Halle Saale
Section for Neonatology and Pediatric Intensive Care, University Hospital Halle Saale
Jena University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of EONS | 3 days after delivery | Primary outcome is the development of EONS defined as the presence of confirmed or suspected sepsis at ≤3 days after birth for which prolonged neonatal antibiotic treatment beyond 72 hours. Confirmed sepsis is established by positive blood cultures whilst suspected sepsis is diagnosed in the presence of clinical suspicion of sepsis (lethargy, apnoea, respiratory distress, hypotension (mean arterial blood pressure (MAD) \< gestational age), hypoperfusion and shock) supported by elevated neonatal C-reactive protein (CRP), interleukin-6 (IL6) or blood film suggestive of bacteraemia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| vaginal CST in PPROM | until delivery | the specific patterns of vaginal CST and vaginal microbiota composition (microbiome) in PPROM |
| neonatal microbial colonisation | up to 2 days after delivery | neonatal microbial colonisation (microbiome) on 1st and 2nd day of life |
Countries
Germany
Contacts
Primary ContactEkkehard Schleußner, Prof. Dr.
Backup ContactJanine Zöllkau, Dr.
Outcome results
None listed