[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620998":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":47,"locations":58,"responsibleParty":95,"collaborators":99,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":52,"maxAge":52,"enrollmentInfo":113,"targetDuration":52,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":52,"overallStatus":61,"whyStopped":52,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Laerdal Foundation","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"FINC arm","EXPERIMENTAL","This arm includes the family of the neonates assigned to the experimental group, and they will receive a FINC intervention. The FINC intervention, families of preterm and low-birth weight neonates aged 0-28 days will be trained, educated, and encouraged to get involved in the newborn care targeted to their neonates.",[13],"Behavioral: Family Integrated Newborn Care, an intervention to integrate family in the care targeted their preterm and Low-birth weight neonates",{"label":15,"type":16,"description":17,"interventionNames":18},"Non-FINC arm","ACTIVE_COMPARATOR","This arm includes the families of the neonates assigned to the comparator group, who will receive conventional or standard care. No special effort that the routine care will be provided to integrate the family into the care targeted to the preterm and low-birth-weight neonates",[19],"Behavioral: Standard medical treatment",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Family Integrated Newborn Care, an intervention to integrate family in the care targeted their preterm and Low-birth weight neonates","The Family Integrated Newborn Care intervention includes undergoing 1) minor modifications in the NCU space and physical infrastructure conducive to family integration; 2) bedside training for families, and 3) provision of ten audio-visual materials in the local language (Tigrigna) demonstrating family integration in key caring activities targeted to their neonates.",[9],[27,28],"Family-Centered care","Family Involvement",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Standard medical treatment","The preterm and low-birth weight neonates will receive the conventional care with no special attention to integrate the families in the care targeted to the neonates",[15],[34],"Conventional newborn care",[36,40,44],{"name":37,"affiliation":38,"role":39},"Siren Rettedal, MD, PhD","1. Faculty of Health Sciences, University of Stavanger, Stavanger, Norway 2. Department of Simulation-based learning, Stavanger University Hospital, Norway","STUDY_CHAIR",{"name":41,"affiliation":42,"role":43},"Hege Prof.Ersdal, MD, PhD","hege.ersdal@safer.net","STUDY_DIRECTOR",{"name":45,"affiliation":46,"role":43},"Damen Hailemariam, MD, PhD","damengoog@gmail.com",[48,54],{"name":49,"role":50,"phone":51,"phoneExt":52,"email":53},"Znabu Hadush Mr.Kahsay, MPH, PhD student","CONTACT","+251 1920874140",null,"znabu.hadish@mu.edu.et",{"name":55,"role":50,"phone":56,"phoneExt":52,"email":57},"Araya Abrha Dr.Medhanyie, PhD","+251933222222","araya.medhanyie@gmail.com",[59,86],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital","RECRUITING","Mek'ele","Tigray","1871","Ethiopia","ET",{"type":68,"coordinates":69},"Point",[70,71],39.47528,13.49667,{"lat":71,"lon":70},[74,78,80,83],{"name":75,"role":50,"phone":76,"phoneExt":52,"email":77},"Znabu Hadush Kahsay, MPH, PhD student","0920874140","hadiszinabu@gmail.com",{"name":55,"role":50,"phone":79,"phoneExt":52,"email":57},"+251 933222222",{"name":81,"role":82,"phone":52,"phoneExt":52,"email":52},"Znabu Hadush Kahsay, MPH, PhD studnet","PRINCIPAL_INVESTIGATOR",{"name":84,"role":85,"phone":52,"phoneExt":52,"email":52},"Araya Abrha Medhanyie, PhD","SUB_INVESTIGATOR",{"facility":60,"status":87,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":88,"geoPoint":90,"contacts":91},"NOT_YET_RECRUITING",{"type":68,"coordinates":89},[70,71],{"lat":71,"lon":70},[92],{"name":93,"role":50,"phone":94,"phoneExt":52,"email":77},"Znabu Hadush Mr. Kahsay, MPH, PhD student","+251-920-874-140",{"type":82,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":98,"oldNameTitle":52,"oldOrganization":52},"Znabu Hadush Kahsay","Principal Investigator","University of Stavanger",[100,102],{"name":101,"class":6},"Mekelle University",{"name":103,"class":6},"Addis Ababa University","100620998","effectiveness-of-family-integrated-newborn-care-to-improve-outcomes-for-preterm-and-low-birth-weight-neonates-100620998",false,"NCT07364903","Effectiveness of Family-Integrated Newborn Care to Improve Outcomes for Preterm and Low-birth-weight Neonates","Effectiveness of Implementing Family-Integrated Newborn Care to Improve Outcomes for Preterm and Low-birth-weight Neonates in Resource-limited Settings; Quasi-experimental Design","FINC","Inclusion Criteria:\n\n* All neonates aged 0-28 days admitted to level-2 NCUs in the neonatal care unit, including Kangaroo Mother care ward or mothers' side ward, with conditions that require hospital stay at 48 hours; and\n* accompanied by at least one parent (preferably a mother) dedicated to spending up to 8 hours per day with the infant\n\nExclusion Criteria:\n\n* Neonates with major congenital anomalies\n* Infants with no family member to accompany the infant, or who do not consent to spend up to 8 hours per day in the NCU\n* Families with confirmed physical and\u002For mental problems limiting their capability to communicate and to engage, or those who leave against medical advice","ALL",{"count":114,"type":115},1020,"ESTIMATED","INTERVENTIONAL",[118],"NA","The goal of this quasi-experimental study is to learn if integrating family in newborn care units as a key partner can improve the outcomes of preterm and low-birth-weight neonates. The main question\\[s\\] that the study aims to answer:\n\n• Does the implementation of the FINC intervention impact the neonatal outcomes for preterm and low-birth weight neonates in NCUs in resource-limited settings of Tigray, Northern Ethiopia? Researchers will compare the Length of hospital stay among preterm and low-birth-weight neonates admitted to hospitals included in the intervention groups and compared to the neonates admitted to hospitals in the control group.\n\nIn the intervention groups, family of preterm and low-birth-weight neonates will be trained, mentored, and integrated into the care targeted to their neonates.",[121,122,123,124],"Family Involvement\u002FEmpowerment","Family-centered Care","Intensive Care Units, Neonatal","Family Integrated Newborn Care","2026-01-18",{"date":127,"type":128},"2026-01-23","ACTUAL",{"date":130,"type":128},"2025-12-16",{"date":132,"type":115},"2026-06-16",{"name":5,"class":6},2]