PPROMPEONSNCT03819192
Predicting EONS in PPROM Patients
An observational study of PPROM and Early-Onset Neonatal Sepsis, run by Jena University Hospital at 2 sites in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- PPROM, Early-Onset Neonatal Sepsis
- What is being tested?
- microbiome analysis, Conventional cultures and CAAP48 measurement
- How many people
- 150 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Feb 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- full age pregnant woman with PPROM and their born preterm infants
- hospitalization between 22+0 and 34+0 weeks of gestation
- multipara possible
Who cannot join
- hospitalization with PPROM before limit of viability are reached
- intrauterine fetal death
- no study agreement
- not able to consent
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Halle/s.
Halle, Saxony-Anhalt, 06097
Michael Bergner, +49345 ext. 557 3250, michael.bergner@uk-halle.de
- Recruiting
Jena University Hospital
Jena, Thuringia, 0774
Jana Pastuschek, Dipl. Biol. M.Sc., +49 3641 ext. 329295, jana.pastuschek@med.uni-jena.de
Yvonne Heimann, M.Sc., +49 3641 ext. 390 868, yvonne.heimann@med.uni-jena.de
About this study
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
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:
- Recruitment, sample collection and routine clinical diagnostics
- Microbiome analysis by 16S rRNA
- 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
- Being tested
- microbiome analysis, Conventional cultures, CAAP48 measurement
- Medical subject headings
- Preterm Premature Rupture of the Membranes, Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microbiome analysisDiagnostic test
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 culturesDiagnostic test
For every sample taken for microbiome analysis, a conventional culture is taken as control.
CAAP48 measurementDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| neonates with signs of EONS | Not described Receives: Diagnostic Test: microbiome analysis; Diagnostic Test: Conventional cultures; Diagnostic Test: CAAP48 measurement | |
| neonates without signs of EONS | Not described Receives: Diagnostic Test: microbiome analysis; Diagnostic Test: Conventional cultures; Diagnostic Test: CAAP48 measurement | |
| pregnant women with PPROM | Not described Receives: Diagnostic Test: microbiome analysis; Diagnostic Test: Conventional cultures; Diagnostic Test: CAAP48 measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days after delivery
Secondary outcomes (2)
vaginal CST in PPROM
the specific patterns of vaginal CST and vaginal microbiota composition (microbiome) in PPROM
Measured: until delivery
neonatal microbial colonisation
neonatal microbial colonisation (microbiome) on 1st and 2nd day of life
Measured: up to 2 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start1 Feb 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PPROMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Center of Fetal Surgery, University Hospital Halle Saale, Section for Neonatology and Pediatric Intensive Care, University Hospital Halle Saale
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819192
- Sponsor's protocol ID
- KG-PEONS
- Acronym
- PEONS
- Status last verified
- Apr 2023
- First submitted
- 23 Jan 2019
- Last updated
- 14 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36907851
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03819192
- Acronym / sponsor ID
- PEONS / KG-PEONS
- Conditions
- PPROM, Early-Onset Neonatal Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Collaborators
- Center of Fetal Surgery, University Hospital Halle Saale, Section for Neonatology and Pediatric Intensive Care, University Hospital Halle Saale
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Recruitment, sample collection and routine clinical diagnostics
- Microbiome analysis by 16S rRNA
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- full age pregnant woman with PPROM and their born preterm infants
- hospitalization between 22+0 and 34+0 weeks of gestation
- multipara possible
Key exclusion criteria (4 listed)
- hospitalization with PPROM before limit of viability are reached
- intrauterine fetal death
- no study agreement
- not able to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microbiome analysisFrom 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. | Diagnostic test | neonates with signs of EONS, neonates without signs of EONS, pregnant women with PPROM |
| Conventional culturesFor every sample taken for microbiome analysis, a conventional culture is taken as control. | Diagnostic test | neonates with signs of EONS, neonates without signs of EONS, pregnant women with PPROM |
| CAAP48 measurementCAAP48 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). | Diagnostic test | neonates with signs of EONS, neonates without signs of EONS, pregnant women with PPROM |
Primary outcome
Development of EONS
Time frame: 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.
2 secondary outcomes
vaginal CST in PPROM
Time frame: until delivery
neonatal microbial colonisation
Time frame: up to 2 days after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Derived from this study: PubMed 36907851Dos 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.
- Individual participant dataSharing planned: No
Related trials for PPROM
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Preterm Prelabor Rupture of Membranes, PPROM
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PPROM and Early-Onset Neonatal Sepsis, run by Jena University Hospital at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ekkehard Schleußner, Prof. Dr. (+49 3641 ext. 932 920, gabriele.schack@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of EONS (time frame: 3 days after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03819192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.