Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-25 @ 2:00 PM
Study NCT ID:
NCT03819192
Status:
UNKNOWN
Last Update Posted:
2023-04-14
First Post:
2019-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predicting EONS in PPROM Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C563032', 'term': 'Preterm Premature Rupture of the Membranes'}, {'id': 'D000071074', 'term': 'Neonatal Sepsis'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2019-01-23', 'studyFirstSubmitQcDate': '2019-01-25', 'lastUpdatePostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of EONS', 'timeFrame': '3 days after delivery', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'vaginal CST in PPROM', 'timeFrame': 'until delivery', 'description': 'the specific patterns of vaginal CST and vaginal microbiota composition (microbiome) in PPROM'}, {'measure': 'neonatal microbial colonisation', 'timeFrame': 'up to 2 days after delivery', 'description': 'neonatal microbial colonisation (microbiome) on 1st and 2nd day of life'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PPROM', 'Early-Onset Neonatal Sepsis']}, 'referencesModule': {'references': [{'pmid': '36907851', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe planned PEONS pilot trial is subdivided in three Work packages:\n\n1. Recruitment, sample collection and routine clinical diagnostics\n2. Microbiome analysis by 16S rRNA\n3. 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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'PPROM cohort = PPROM patients (hospitalization between 22+0 - 34+0 weeks of gestation) and their born preterm neonates, n = 65\n\n* Subgroup 1: with EONS, n = 15\n* Subgroup 2: without EONS, n = 50', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* full age pregnant woman with PPROM and their born preterm infants\n* hospitalization between 22+0 and 34+0 weeks of gestation\n* multipara possible\n\nExclusion Criteria:\n\n* hospitalization with PPROM before limit of viability are reached\n* intrauterine fetal death\n* no study agreement\n* not able to consent'}, 'identificationModule': {'nctId': 'NCT03819192', 'acronym': 'PEONS', 'briefTitle': 'Predicting EONS in PPROM Patients', 'organization': {'class': 'OTHER', 'fullName': 'Jena University Hospital'}, 'officialTitle': 'Prediction of Early-Onset Neonatal Sepsis (EONS) in Pregnant Women With Preterm Premature Rupture of Membranes (PPROM) by Vaginal Microbiome Analysis - a Pilot Study', 'orgStudyIdInfo': {'id': 'KG-PEONS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'neonates with signs of EONS', 'interventionNames': ['Diagnostic Test: microbiome analysis', 'Diagnostic Test: Conventional cultures', 'Diagnostic Test: CAAP48 measurement']}, {'label': 'neonates without signs of EONS', 'interventionNames': ['Diagnostic Test: microbiome analysis', 'Diagnostic Test: Conventional cultures', 'Diagnostic Test: CAAP48 measurement']}, {'label': 'pregnant women with PPROM', 'interventionNames': ['Diagnostic Test: microbiome analysis', 'Diagnostic Test: Conventional cultures', 'Diagnostic Test: CAAP48 measurement']}], 'interventions': [{'name': 'microbiome analysis', 'type': 'DIAGNOSTIC_TEST', 'description': 'From all full age pregnant women with PPROM enrolled in this study vaginal smear samples will be taken at three time points:\n\n1. directly after hospitalization\n2. 5-7 days after beginning of antibiotic treatment\n3. 24 h before birth\n\nThe 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.', 'armGroupLabels': ['neonates with signs of EONS', 'neonates without signs of EONS', 'pregnant women with PPROM']}, {'name': 'Conventional cultures', 'type': 'DIAGNOSTIC_TEST', 'description': 'For every sample taken for microbiome analysis, a conventional culture is taken as control.', 'armGroupLabels': ['neonates with signs of EONS', 'neonates without signs of EONS', 'pregnant women with PPROM']}, {'name': 'CAAP48 measurement', 'type': 'DIAGNOSTIC_TEST', 'description': '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).', 'armGroupLabels': ['neonates with signs of EONS', 'neonates without signs of EONS', 'pregnant women with PPROM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06097', 'city': 'Halle', 'state': 'Saxony-Anhalt', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Bergner', 'role': 'CONTACT', 'email': 'michael.bergner@uk-halle.de', 'phone': '+49345', 'phoneExt': '557 3250'}], 'facility': 'University Hospital Halle/s.', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '0774', 'city': 'Jena', 'state': 'Thuringia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jana Pastuschek, Dipl. Biol. M.Sc.', 'role': 'CONTACT', 'email': 'jana.pastuschek@med.uni-jena.de', 'phone': '+49 3641', 'phoneExt': '329295'}, {'name': 'Yvonne Heimann, M.Sc.', 'role': 'CONTACT', 'email': 'yvonne.heimann@med.uni-jena.de', 'phone': '+49 3641', 'phoneExt': '390 868'}], 'facility': 'Jena University Hospital', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'centralContacts': [{'name': 'Ekkehard Schleußner, Prof. Dr.', 'role': 'CONTACT', 'email': 'gabriele.schack@med.uni-jena.de', 'phone': '+49 3641', 'phoneExt': '932 920'}, {'name': 'Janine Zöllkau, Dr.', 'role': 'CONTACT', 'email': 'studien.geburtsmedizin@med.uni-jena.de', 'phone': '+49 3641', 'phoneExt': '932 92 18'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jena University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Center of Fetal Surgery, University Hospital Halle Saale', 'class': 'UNKNOWN'}, {'name': 'Section for Neonatology and Pediatric Intensive Care, University Hospital Halle Saale', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}