Predicting EONS in PPROM Patients

Recruiting

• Conditions: PPROM; Early-Onset Neonatal Sepsis
• Interventions: Diagnostic Test: microbiome analysis; Diagnostic Test: Conventional cultures; Diagnostic Test: CAAP48 measurement

• Registration Number: NCT03819192
• Lead Sponsor: Jena University Hospital

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:

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-28
• Study Start: 2019-02-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-14
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
neonates without signs of EONS	microbiome analysis	-
neonates without signs of EONS	Conventional cultures	-
neonates with signs of EONS	CAAP48 measurement	-
neonates with signs of EONS	microbiome analysis	-
neonates with signs of EONS	Conventional cultures	-
neonates without signs of EONS	CAAP48 measurement	-
pregnant women with PPROM	microbiome analysis	-
pregnant women with PPROM	CAAP48 measurement	-
pregnant women with PPROM	Conventional cultures	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

University Hospital Halle/s.; 🇩🇪 Halle (Saale), Saxony-Anhalt, Germany

Jena University Hospital; 🇩🇪 Jena, Thuringe, Germany