PEONS: Predicting EONS in PPROM Patients
Study Details
Study Description
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:
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Recruitment, sample collection and routine clinical diagnostics
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Microbiome analysis by 16S rRNA
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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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| neonates with signs of EONS
|
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:
directly after hospitalization
5-7 days after beginning of antibiotic treatment
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 measurment
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).
|
| neonates without signs of EONS
|
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:
directly after hospitalization
5-7 days after beginning of antibiotic treatment
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 measurment
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).
|
| pregnant women with PPROM
|
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:
directly after hospitalization
5-7 days after beginning of antibiotic treatment
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 measurment
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).
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
full age pregnant woman with PPROM and their born preterm infants
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hospitalization between 22+0 and 34+0 weeks of gestation
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multipara possible
Exclusion Criteria:
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hospitalization with PPROM before limit of viability are reached
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intrauterine fetal death
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no study agreement
-
not able to consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Halle/s. | Halle (Saale) | Saxony-Anhalt | Germany | 06097 |
| 2 | Jena University Hospital | Jena | Thuringe | Germany | 0774 |
Sponsors and Collaborators
- Jena University Hospital
- Center of Fetal Surgery, University Hospital Halle Saale
- Section for Neonatology and Pediatric Intensive Care, University Hospital Halle Saale
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KG-PEONS