[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100461311":3},{"organization":4,"armGroups":7,"interventions":45,"overallOfficials":51,"centralContacts":56,"locations":65,"responsibleParty":95,"collaborators":98,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":10,"eligibilityCriteria":107,"healthyVolunteers":108,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":10,"studyType":115,"phases":10,"briefSummary":116,"conditions":117,"keywords":10,"overallStatus":82,"whyStopped":10,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"University of Giessen","OTHER",[8,12,17,21,24,27,30,33,36,39,42],{"label":9,"type":10,"description":11,"interventionNames":10},"K0 - baseline cohort",null,"45 preterm infants and their parents (average number of patient admissions per 6 months during the last 5 years)",{"label":13,"type":10,"description":14,"interventionNames":15},"K1 - 1st intervention cohort","All preterm infants and their parents enrolled during the first 6 months period after completion of the baseline cohort and who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.",[16],"Behavioral: Family Centred Care (FCC) interventions as potentially better practices (PBPs)",{"label":18,"type":10,"description":19,"interventionNames":20},"K2 - 2nd intervention cohort","All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.",[16],{"label":22,"type":10,"description":19,"interventionNames":23},"K3 - 3rd intervention cohort",[16],{"label":25,"type":10,"description":19,"interventionNames":26},"K4 - 4th intervention cohort",[16],{"label":28,"type":10,"description":19,"interventionNames":29},"K5 - 5th intervention cohort",[16],{"label":31,"type":10,"description":19,"interventionNames":32},"K6 - 6th intervention cohort",[16],{"label":34,"type":10,"description":19,"interventionNames":35},"K7 - 7th intervention cohort",[16],{"label":37,"type":10,"description":19,"interventionNames":38},"K8 - 8th intervention cohort",[16],{"label":40,"type":10,"description":19,"interventionNames":41},"K9 - 9th intervention cohort",[16],{"label":43,"type":10,"description":19,"interventionNames":44},"K10 - 10th intervention cohort",[16],[46],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":10},"BEHAVIORAL","Family Centred Care (FCC) interventions as potentially better practices (PBPs)","After the previous period, additional Family Centred Care (FCC) elements will be introduced gradually every 6 months, covering staff training, parent education, psychosocial support for families, and last but not least, the neonatal intensive care unit environment.\n\nThe focus group consisting of nurses and healthcare professionals will meet regularly and will decide on new FCC interventions as potentially better practices (PBPs). New additional PBPs will be disseminated into the greater team through workshops, hands-on teaching, displays, etc. Potential PBPs for our department enclose:\n\nParent participation on rounds Parent skill self-assessment Parent-to-parent support Regular staff education Improvement of psychosocial support Improvement of neonatal unit surroundings to promote parent-infant-closeness",[13,43,18,22,25,28,31,34,37,40],[52],{"name":53,"affiliation":54,"role":55},"Rahel Schuler","Department of General Pediatrics and Neonatology, Justus- Liebig- University, Giessen, Germany","PRINCIPAL_INVESTIGATOR",[57,62],{"name":58,"role":59,"phone":60,"phoneExt":10,"email":61},"Rahel Schuler, Dr.","CONTACT","+4964198558821","rahel.schuler@paediat.med.uni-giessen.de",{"name":63,"role":59,"phone":10,"phoneExt":10,"email":64},"Harald Ehrhardt, Prof.","harald.ehrhardt@paediat.med.uni-giessen.de",[66,80],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":10},"Mihatsch Walter","ACTIVE_NOT_RECRUITING","Ulm","Baden-Wurttemberg","89231","Germany","DE",{"type":75,"coordinates":76},"Point",[77,78],9.99155,48.39841,{"lat":78,"lon":77},{"facility":81,"status":82,"city":83,"state":84,"zip":85,"country":72,"countryCode":73,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Department of General Pediatrics and Neonatology, Justus- Liebig- University, Feulgenstrasse 12, D-35392 Giessen, Germany","RECRUITING","Giessen","Hesse","35390",{"type":75,"coordinates":87},[88,89],8.67554,50.58727,{"lat":89,"lon":88},[92,93],{"name":53,"role":59,"phone":60,"phoneExt":10,"email":61},{"name":94,"role":59,"phone":10,"phoneExt":10,"email":64},"Harald Ehrhardt",{"type":55,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Dr. Rahel Schuler","Consultant Neonatology",[99],{"name":100,"class":6},"University of Ulm","100461311","multidimensional-assessment-of-infant-parent-and-staff-outcomes-during-a-family-centered-care-enhancement-project-100461311",false,"NCT05286983","Multidimensional Assessment of Infant, Parent and Staff Outcomes During a Family Centered Care Enhancement Project","Multidimensional Assessment of Infant, Parent and Staff Outcomes During a Family Centered Care Enhancement Project in a Tertiary Neonatal Intensive Care","Inclusion Criteria:\n\n* ≤32+0 weeks of gestational age (GA) and\u002For birthweight ≤1500g\n* biparental (or guardian) written informed consent\n\nExclusion Criteria:\n\n* severe congenital anomalies (e.g. cyanotic heart disease, severe lung hypoplasia, congenital diaphragmatic hernia)\n* decision not to provide full life support\n* decision for palliative care before study entry\n* parents with severe psychiatric disease",true,"ALL","1 Minute","14 Days",{"count":113,"type":114},495,"ESTIMATED","OBSERVATIONAL","This prospective single centre longitudinal cohort study enrols preterm infants ≤32+0 weeks of gestation and\u002For birthweight ≤1500g and their parents. Following a baseline period additional Family Centred Care elements are introduced as potentially better practices, these elements focus on four areas: the NICU (Neonatal Intensive Care Unit) environment, staff training, parental education and psychosocial support to the families. The effect of the implementation of additional Family Centred Care elements on infant, parent and staff outcomes are assessed. The parallel data collection enables to study the interrelation between these three important areas of research.",[118],"Family Centered Care","2025-03-25",{"date":121,"type":122},"2025-03-30","ACTUAL",{"date":124,"type":122},"2020-10-01",{"date":126,"type":114},"2026-07-01",{"name":5,"class":6},2]