Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2019-02-01
2023-12-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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neonates with signs of EONS
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.
Conventional cultures
For every sample taken for microbiome analysis, a conventional culture is taken as control.
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).
neonates without signs of EONS
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.
Conventional cultures
For every sample taken for microbiome analysis, a conventional culture is taken as control.
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).
pregnant women with PPROM
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.
Conventional cultures
For every sample taken for microbiome analysis, a conventional culture is taken as control.
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).
Interventions
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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.
Conventional cultures
For every sample taken for microbiome analysis, a conventional culture is taken as control.
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).
Eligibility Criteria
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Inclusion Criteria
* hospitalization between 22+0 and 34+0 weeks of gestation
* multipara possible
Exclusion Criteria
* intrauterine fetal death
* no study agreement
* not able to consent
18 Years
FEMALE
No
Sponsors
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Center of Fetal Surgery, University Hospital Halle Saale
UNKNOWN
Section for Neonatology and Pediatric Intensive Care, University Hospital Halle Saale
UNKNOWN
Jena University Hospital
OTHER
Responsible Party
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Locations
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University Hospital Halle/s.
Halle, Saxony-Anhalt, Germany
Jena University Hospital
Jena, Thuringia, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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KG-PEONS
Identifier Type: -
Identifier Source: org_study_id
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