[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596434":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":44,"locations":54,"responsibleParty":65,"collaborators":24,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":24,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":24,"overallStatus":56,"whyStopped":24,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Fenerbahce University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Kangaroo Care + Maternal Voice + Fetal Position Group","EXPERIMENTAL","Infants in this group, once clinically stable, will receive kangaroo care with their mothers for one hour, at least five days a week, immediately after their enteral feeding until they transition to full oral feeding. During the first 15 minutes of skin-to-skin contact, the mother will tell a story to the infant. After the kangaroo care, the infants will be placed in an incubator, and a lateral fetal position will be maintained for half an hour. During this process, no intervention will be made unless necessary.\n\nUntil the infant transitions to full oral feeding, comfort will be assessed once a day, at least five days a week, using the Neonatal Comfort Behavior Scale: before feeding, immediately before finishing kangaroo care (at 60 minutes), and 30 minutes after the fetal position (at 90 minutes). On the days kangaroo care is applied, before feeding, the infant will be weighed using a ±10-gram sensitive digital baby scale, and their length and head circumference will be measured with",[13],"Other: Kangaroo Care + Maternal Voice + Fetal Position Group",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group: (Fetal Position group)","ACTIVE_COMPARATOR","Infants in this group, whose mothers are unavailable, will receive only lateral fetal positioning for one and a half hours immediately after their enteral feeding, at least five days a week, until they transition to full oral feeding, in the incubator.\n\nUntil the infant transitions to full oral feeding, the same measurements will be taken and recorded as those for the Kangaroo Group.",[19],"Other: control group",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"After ethical approval, all infants with a gestational age between 30-34 weeks in Neonatal Intensive Care Unit will be assessed. Parents of eligible infants will be informed about the study and asked to provide written consent. The infants will then be assigned to one of two groups: kangaroo care + mother's voice + fetal position (n=34) or fetal position only (n=34). In the first group, after tube feeding, infants will receive one hour of kangaroo care with the mother, including reading a story for the first 15 minutes. After finishing kangaroo care,they will then be placed in a fetal position in an incubator for 30 minutes. Comfort levels, weight, length, and head circumference will be measured daily until oral feeding begins, and the impact of kangaroo care and the mother's voice on the transition to full oral feeding will be assessed. All procedures will occur between 08:00 and 16:00.",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"control group","After ethical approval, all infants with a gestational age between 30-34 weeks in the Neonatal Intensıve Care Unit will be assessed. Parents of eligible infants will be informed about the study and asked to provide written consent. If infant is in the fetal position group, after being fed by a oral gastric tube, they will be placed in an incubator and positioned in a fetal position similar to that in the womb for one and a half hours. During all these procedures, infant's comfort levels will be assessed using a scale (form), and their weight, length, and head circumference will be measured every morning until they begin oral feeding. Additionally, the effect of the fetal position on infant's transition to full oral feeding will be evaluated.All procedures will take place between 08:00 and 16:00.",[15],[30,33,37,39,42],{"name":31,"affiliation":5,"role":32},"Canan GENÇ, Ph.D student","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":35,"role":36},"Duygu Gözen, Ph.D","Koç University","STUDY_CHAIR",{"name":38,"affiliation":5,"role":36},"NEGARIN Akbari, Ph.D",{"name":40,"affiliation":41,"role":32},"Melek Selalmaz, Ms.c","ŞİŞLİ HAMİDİYE ETFAL TRAINING AND RESEARCH HOSPITAL",{"name":43,"affiliation":41,"role":32},"Ali Bulbul, Doctor",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":24,"email":49},"Negarin Akbari, Ph.D","CONTACT","00905352679510","negarin.akbari@fbu.edu.tr",{"name":51,"role":47,"phone":52,"phoneExt":24,"email":53},"Duygu GÖZEN, Ph.D","05327065065","duygu.gozen@iuc.edu.tr",[55],{"facility":5,"status":56,"city":57,"state":24,"zip":24,"country":58,"countryCode":24,"cosmosGeoPoint":59,"geoPoint":64,"contacts":24},"RECRUITING","Istanbul","Turkey (Türkiye)",{"type":60,"coordinates":61},"Point",[62,63],28.94966,41.01384,{"lat":63,"lon":62},{"type":32,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Negarin Akbari","Assisstant Professor","100596434","effect-of-developmental-care-on-comfort-growth-and-oral-feeding-transition-in-preterm-infants-100596434",false,"NCT07045402","Effect of Developmental Care on Comfort, Growth, and Oral Feeding Transition in Preterm Infants","The Effect of Kangaroo Care and Maternal Voice on Comfort, Anthropometric Measurements, and Transition to Oral Feeding in Preterm Infants","KCareInfant","Inclusion Criteria:\n\n1. Infants with a gestational age between 30-34 weeks.\n2. The mother's ability to read and write.\n3. The infant must be fully enterally fed at the time of enrollment in the study.\n4. Infants who are being fed via orogastric tube at the time of enrollment.\n5. Infants whose mothers agree to engage in skin-to-skin contact for 1 hour, five sessions per week, with auditory stimulation (storytelling) for 15 minutes will be included in the study.\n6. Infants whose mothers cannot participate in the study (due to health issues or other reasons) or refuse kangaroo care will be placed in the control group, where routine service care will be applied.\n\nExclusion Criteria:\n\n1. Presence of a congenital anomaly or genetic disease.\n2. Requirement of ventilator support.\n3. Infants receiving antibiotics for sepsis or suspected sepsis.\n4. Administration of sedative treatment.\n5. Having an intracranial hemorrhage greater than grade II.\n6. The mother having a physical condition that prevents skin-to-skin contact.\n7. The mother using substances or alcohol.",true,"ALL","30 Weeks","34 Weeks",{"count":81,"type":82},68,"ESTIMATED","INTERVENTIONAL",[85],"NA","This randomized controlled study aims to evaluate the effects of kangaroo care combined with maternal voice and fetal positioning on the comfort, growth, and transition to full oral feeding in preterm infants aged 30 to 34 weeks gestation. After ethical approval, eligible infants in the neonatal clinic will be randomly assigned to either the intervention group receiving kangaroo care, maternal voice, and fetal positioning, or a control group receiving only fetal positioning in the incubator. The intervention involves daily one-hour kangaroo care sessions with maternal storytelling, followed by positioning in the lateral fetal posture, continuing at least five days per week until infants achieve full oral feeding. Infant comfort will be assessed regularly using the Neonatal Comfort Behavior Scale before feeding, immediately after kangaroo care, and after fetal positioning. Growth parameters, including weight, length, and head circumference, will be measured and recorded on kangaroo care days. The control group will receive routine fetal positioning without kangaroo care, with identical measurements taken. The study aims to determine whether kangaroo care combined with maternal voice and fetal positioning improves infant comfort, supports growth, and facilitates the transition to full oral feeding in preterm newborns.",[88,89,90,91,92,93],"Infant, Premature","Kangaroo Mother Care","Comfort","Feeding","Oral Feeding Performance","Facilitated Tucking","2025-09-03",{"date":96,"type":97},"2025-09-04","ACTUAL",{"date":99,"type":97},"2025-02-10",{"date":101,"type":82},"2026-03-10",{"name":5,"class":6},1]