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).
Study Type
OBSERVATIONAL
Enrollment
150
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.
For every sample taken for microbiome analysis, a conventional culture is taken as control.
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).
University Hospital Halle/s.
Halle, Saxony-Anhalt, Germany
RECRUITINGJena University Hospital
Jena, Thuringia, Germany
RECRUITINGDevelopment 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.
Time frame: 3 days after delivery
vaginal CST in PPROM
the specific patterns of vaginal CST and vaginal microbiota composition (microbiome) in PPROM
Time frame: until delivery
neonatal microbial colonisation
neonatal microbial colonisation (microbiome) on 1st and 2nd day of life
Time frame: up to 2 days after delivery
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