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| Name | Class |
|---|---|
| Center of Fetal Surgery, University Hospital Halle Saale | UNKNOWN |
| Section for Neonatology and Pediatric Intensive Care, University Hospital Halle Saale | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neonates with signs of EONS |
| ||
| neonates without signs of EONS |
| ||
| pregnant women with PPROM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| microbiome analysis | Diagnostic Test | From all full age pregnant women with PPROM enrolled in this study vaginal smear samples will be taken at three time points:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| Development of EONS | 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. | 3 days after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| vaginal CST in PPROM | the specific patterns of vaginal CST and vaginal microbiota composition (microbiome) in PPROM | until delivery |
| neonatal microbial colonisation | neonatal microbial colonisation (microbiome) on 1st and 2nd day of life |
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Inclusion Criteria:
Exclusion Criteria:
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PPROM cohort = PPROM patients (hospitalization between 22+0 - 34+0 weeks of gestation) and their born preterm neonates, n = 65
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ekkehard Schleußner, Prof. Dr. | Contact | +49 3641 | 932 920 | gabriele.schack@med.uni-jena.de |
| Janine Zöllkau, Dr. | Contact | +49 3641 | 932 92 18 | studien.geburtsmedizin@med.uni-jena.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Halle/s. | Recruiting | Halle | Saxony-Anhalt | 06097 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36907851 | Derived | Dos Anjos Borges LG, Pastuschek J, Heimann Y, Dawczynski K; PEONS study group; Schleussner E, Pieper DH, Zollkau J. Vaginal and neonatal microbiota in pregnant women with preterm premature rupture of membranes and consecutive early onset neonatal sepsis. BMC Med. 2023 Mar 13;21(1):92. doi: 10.1186/s12916-023-02805-x. |
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| ID | Term |
|---|---|
| C563032 | Preterm Premature Rupture of the Membranes |
| D000071074 | Neonatal Sepsis |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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|
| Conventional cultures | Diagnostic Test | For every sample taken for microbiome analysis, a conventional culture is taken as control. |
|
| CAAP48 measurement | Diagnostic Test | 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). |
|
| up to 2 days after delivery |
| Jena University Hospital | Recruiting | Jena | Thuringia | 0774 | Germany |
|
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |