Predicting EONS in PPROM Patients

Early-Onset Neonatal Sepsis Clinical Trial

— PEONS  

Official title:

Prediction of Early-Onset Neonatal Sepsis (EONS) in Pregnant Women With Preterm Premature Rupture of Membranes (PPROM) by Vaginal Microbiome Analysis - a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03819192
• Other study ID #: KG-PEONS
• Status: Recruiting
• Start date: February 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Jena University Hospital
• Contact: Ekkehard Schleußner, Prof. Dr.
• Phone: +49 3641
• Email: gabriele.schack[@]med.uni-jena.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Early-Onset Neonatal Sepsis
• Neonatal Sepsis
• PPROM
• Sepsis

Intervention

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.
• 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).

Locations

Country	Name	City	State
Germany	University Hospital Halle/s.	Halle (Saale)	Saxony-Anhalt
Germany	Jena University Hospital	Jena	Thuringe

Sponsors (3)

Lead Sponsor	Collaborator
Jena University Hospital	Center of Fetal Surgery, University Hospital Halle Saale, Section for Neonatology and Pediatric Intensive Care, University Hospital Halle Saale

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	vaginal CST in PPROM	the specific patterns of vaginal CST and vaginal microbiota composition (microbiome) in PPROM	until delivery
Secondary	neonatal microbial colonisation	neonatal microbial colonisation (microbiome) on 1st and 2nd day of life	up to 2 days after delivery