protocolSection identificationModule nctId: NCT06379828, orgStudyIdInfo id: 2024-0140, briefTitle: Self-assessment Tool for Implementing the ESCNH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-03, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: European Foundation for the Care of Newborn Infants, class: OTHER, descriptionModule briefSummary: This study aims to develop a tool for hospitals to self-assess the implementation of the European Standards of Care for Newborn Health (ESCNH), standards defining best-practice procedures for neonatal care. The tool shall support healthcare professionals across Europe to measure the level of implementation of the ESCNH, to identify variations in care delivery, and ultimately to improve neonatal care. To achieve this, healthcare professionals from all relevant backgrounds and parent representatives will be invited to take part in an electronic Delphi consensus approach. A subsequent pilot-testing among at least 10 hospitals across Europe will refine the developed tool, indicate potential errors, ensure user-friendliness, and improve the applicability., conditionsModule conditions: Development of a Tool to Assess the Level of Implementing the European Standards of Care for Newborn Health, conditions: Testing of the Developed Self-assessment Tool in European Hospitals, conditions: Self-Assessment, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Please note that this is an observational study; not applicable, outcomesModule primaryOutcomes measure: Online self-assessment tool (including statements and questions), secondaryOutcomes measure: Response rates, secondaryOutcomes measure: Demographics and characteristics, secondaryOutcomes measure: User-friendliness score of the self-assessment tool, secondaryOutcomes measure: Applicability score of the formulation of the questions, secondaryOutcomes measure: Qualitative feedback on illustration of output, secondaryOutcomes measure: Appraisal on the utilisation of the self-assessment tool, secondaryOutcomes measure: Scalability of the self-assessment tool and dissemination, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Foundation for the Care of Newborn Infants (EFCNI), city: Munich, state: Bavaria, zip: 81379, country: Germany, contacts name: Isabel Geiger, Dr., role: CONTACT, phone: 0049 89 89 0 83 26-0, email: isabel.geiger@efcni.org, contacts name: Julia Hoffmann, Dr., role: CONTACT, email: julia.hoffmann@efcni.org, contacts name: Luc Zimmermann, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.13743, lon: 11.57549, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-04-17, uploadDate: 2024-04-17T07:49, filename: Prot_SAP_000.pdf, size: 200372, hasResults: False