Predicting EONS in PPROM Patients

NCT03819192 | Unknown

• 1 other identifier: KG-PEONS
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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. 1.Recruitment, sample collection and routine clinical diagnostics
2. 2.Microbiome analysis by 16S rRNA
3. 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).

Conditions

PPROM; Early-Onset Neonatal Sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• vaginal CST in PPROM

  until delivery

• neonatal microbial colonisation

  up to 2 days after delivery

Study Arms (3)

neonates with signs of EONS

Diagnostic Test: microbiome analysis; Diagnostic Test: Conventional cultures; Diagnostic Test: CAAP48 measurement

neonates without signs of EONS

Diagnostic Test: microbiome analysis; Diagnostic Test: Conventional cultures; Diagnostic Test: CAAP48 measurement

pregnant women with PPROM

Diagnostic Test: microbiome analysis; Diagnostic Test: Conventional cultures; Diagnostic Test: CAAP48 measurement

Interventions

microbiome analysis DIAGNOSTIC_TEST

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.

neonates with signs of EONS; neonates without signs of EONS; pregnant women with PPROM

Conventional cultures DIAGNOSTIC_TEST

For every sample taken for microbiome analysis, a conventional culture is taken as control.

neonates with signs of EONS; neonates without signs of EONS; pregnant women with PPROM

CAAP48 measurement DIAGNOSTIC_TEST

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 with signs of EONS; neonates without signs of EONS; pregnant women with PPROM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

PPROM cohort = PPROM patients (hospitalization between 22+0 - 34+0 weeks of gestation) and their born preterm neonates, n = 65 * Subgroup 1: with EONS, n = 15 * Subgroup 2: without EONS, n = 50

You may qualify if:

• full age pregnant woman with PPROM and their born preterm infants
• hospitalization between 22+0 and 34+0 weeks of gestation
• multipara possible

You may not qualify if:

• hospitalization with PPROM before limit of viability are reached
• intrauterine fetal death
• no study agreement
• not able to consent

Sponsors & Collaborators

• Jena University Hospital: lead
• Center of Fetal Surgery, University Hospital Halle Saale: collaborator
• Section for Neonatology and Pediatric Intensive Care, University Hospital Halle Saale: collaborator

Study Sites (2)

University Hospital Halle/s.

Halle, Saxony-Anhalt, 06097, Germany

RECRUITING

Jena University Hospital

Jena, Thuringia, 0774, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 36907851 DERIVED

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes; Neonatal Sepsis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ekkehard Schleußner, Prof. Dr.

CONTACT

+49 3641; gabriele.schack@med.uni-jena.de

Janine Zöllkau, Dr.

CONTACT

+49 3641; studien.geburtsmedizin@med.uni-jena.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 28, 2019
• Study Start: February 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)