[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620998":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":45,"studyPopulation":38,"armGroups":46,"interventions":59,"overallOfficials":74,"centralContacts":86,"locations":96,"responsibleParty":133,"collaborators":137,"id":142,"slug":143,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":144,"sex":150,"minAge":38,"maxAge":38,"enrollmentInfo":151,"targetDuration":38,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":38,"overallStatus":99,"whyStopped":38,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"Laerdal Foundation","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"Length of hospital stay","It refers to the duration a neonate stays in the hospital for care, starting from admission to discharge home","The period from the date of admission to the date of discharge is within the first 28 days of neonat's life.",[14,18,22,26,29,32,35],{"measure":15,"description":16,"timeFrame":17},"Survival at discharge","Survival status of the neonate at discharge, specified as alive, dead, or referred for higher-level care, or left against medical advice.","Starting from date of admission to the date of discharge within the first 28 days of the neonate's life",{"measure":19,"description":20,"timeFrame":21},"Daily weight gain","The net weight gain of a neonate each day (in grams\u002Fkg\u002Fday) in reference to the expected gain for the body mass","Starting from the date of admission up to the date of discharge and assessed in the first 28 days of the neonate's life",{"measure":23,"description":24,"timeFrame":25},"Time to initiate breastfeeding after admission","The time the breastfeeding of the neonate is initiated for the first time since admission","Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life",{"measure":27,"description":28,"timeFrame":25},"Time to initiate skin-to-skin after admission","The first time skin-to-skin is initiated for the neonate, since the date of admission to the Neonatal Intensive Care Unit (NICU)",{"measure":30,"description":31,"timeFrame":25},"The number of days on Antibiotics","The total number of days the neonate received antibiotics for being suspected or diagnosed with sepsis",{"measure":33,"description":34,"timeFrame":25},"Score for parental stress monitoring scale","A score for the parental stress monitoring scale, which consists of eight items in a five-point Likert scale, with scores ranging from a lower score (1= Not stressful at all) to a higher score (5= Extremely stressful).",{"measure":36,"description":37,"timeFrame":25},"Discharge readiness score on the day of the discharge","The score for the discharge readiness scale, consisting of eight items in a five-point Likert scale, to assess parents' readiness at the time of discharge. The score level ranges from a lower score (1= Extremely low confidence) to a higher score (5= Extremely high confidence).",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":38,"primaryPurpose":42,"observationalModel":38,"timePerspective":38,"maskingInfo":43},"NON_RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":44,"maskingDescription":38,"whoMasked":38},"NONE","The World Health Organization recommends Family involvement and support in the management of preterm and low birth weight neonates. However, the body of literature on its effectiveness in low-resource settings is scanty. The current study aimed to investigate the effectiveness of implementing Family-Integrated Newborn Care to improve outcomes for preterm and low-birth weight Neonates in resource-limited settings in resource-limited settings of Ethiopia. A quasi-experimental design with non-equivalent comparison groups will be employed among 1020 family-neonate dyads in three hospitals with level-2 Neonatal Care Units. The intervention package will mainly consist of training and education sessions for health care providers and families supplemented by measures to ensure infection prevention in level-2 neonatal care units. The effect size of implementing Family-Integrated Newborn Care on neonatal and parental outcomes will be estimated using General Linear Models (GLM) and compared with the conventional care. Research questions are:\n\n1. 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?\n2. Was the uptake of implementation of the FINC intervention for preterm and low-birth-weight neonates acceptable?",[47,53],{"label":48,"type":49,"description":50,"interventionNames":51},"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.",[52],"Behavioral: Family Integrated Newborn Care, an intervention to integrate family in the care targeted their preterm and Low-birth weight neonates",{"label":54,"type":55,"description":56,"interventionNames":57},"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",[58],"Behavioral: Standard medical treatment",[60,68],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"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.",[48],[66,67],"Family-Centered care","Family Involvement",{"type":61,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"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",[54],[73],"Conventional newborn care",[75,79,83],{"name":76,"affiliation":77,"role":78},"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":80,"affiliation":81,"role":82},"Hege Prof.Ersdal, MD, PhD","hege.ersdal@safer.net","STUDY_DIRECTOR",{"name":84,"affiliation":85,"role":82},"Damen Hailemariam, MD, PhD","damengoog@gmail.com",[87,92],{"name":88,"role":89,"phone":90,"phoneExt":38,"email":91},"Znabu Hadush Mr.Kahsay, MPH, PhD student","CONTACT","+251 1920874140","znabu.hadish@mu.edu.et",{"name":93,"role":89,"phone":94,"phoneExt":38,"email":95},"Araya Abrha Dr.Medhanyie, PhD","+251933222222","araya.medhanyie@gmail.com",[97,124],{"facility":98,"status":99,"city":100,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":111},"Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital","RECRUITING","Mek'ele","Tigray","1871","Ethiopia","ET",{"type":106,"coordinates":107},"Point",[108,109],39.47528,13.49667,{"lat":109,"lon":108},[112,116,118,121],{"name":113,"role":89,"phone":114,"phoneExt":38,"email":115},"Znabu Hadush Kahsay, MPH, PhD student","0920874140","hadiszinabu@gmail.com",{"name":93,"role":89,"phone":117,"phoneExt":38,"email":95},"+251 933222222",{"name":119,"role":120,"phone":38,"phoneExt":38,"email":38},"Znabu Hadush Kahsay, MPH, PhD studnet","PRINCIPAL_INVESTIGATOR",{"name":122,"role":123,"phone":38,"phoneExt":38,"email":38},"Araya Abrha Medhanyie, PhD","SUB_INVESTIGATOR",{"facility":98,"status":125,"city":100,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":126,"geoPoint":128,"contacts":129},"NOT_YET_RECRUITING",{"type":106,"coordinates":127},[108,109],{"lat":109,"lon":108},[130],{"name":131,"role":89,"phone":132,"phoneExt":38,"email":115},"Znabu Hadush Mr. Kahsay, MPH, PhD student","+251-920-874-140",{"type":120,"investigatorFullName":134,"investigatorTitle":135,"investigatorAffiliation":136,"oldNameTitle":38,"oldOrganization":38},"Znabu Hadush Kahsay","Principal Investigator","University of Stavanger",[138,140],{"name":139,"class":6},"Mekelle University",{"name":141,"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":152,"type":153},1020,"ESTIMATED","INTERVENTIONAL",[156],"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.",[159,160,161,162],"Family Involvement\u002FEmpowerment","Family-centered Care","Intensive Care Units, Neonatal","Family Integrated Newborn Care","2026-01-18",{"date":165,"type":166},"2026-01-23","ACTUAL",{"date":168,"type":166},"2025-12-16",{"date":170,"type":153},"2026-06-16",{"name":5,"class":6},2]