[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625144":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":18,"responsibleParty":34,"collaborators":18,"id":38,"slug":18,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":18,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":18,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":59,"overallStatus":64,"whyStopped":18,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":18},{"fullName":5,"class":6},"Erzurum Technical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Infant Massage Group","EXPERIMENTAL","The massage application consists of gentle tactile stimulation targeting the extremities and lymphatic drainage pathways. The therapy is performed for 15 minutes once daily for 14 days by a trained researcher\u002Fnurse. The technique is adapted for preterm physiology to ensure safety and comfort.",[13],"Behavioral: Infant Massage Group",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Routine clinical management provided to preterm infants in the NICU, including standard medical treatment, feeding, positioning, and hygiene care according to the unit's protocols.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","The intervention involves a standardized infant massage therapy protocol applied by a trained researcher. The massage consists of gentle tactile stimulation targeting the upper and lower extremities to facilitate lymphatic drainage. The sessions are conducted for 15 minutes, once daily, for a period of 14 consecutive days. This intervention is provided in addition to standard NICU care.",[9],[25],{"name":26,"affiliation":5,"role":27},"Ayşe Gürol, PhD","STUDY_DIRECTOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},"Birgül Tuncay, PhD","CONTACT","05337615764","birgul.tuncay@erzurum.edu.tr",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Birgül Tuncay","Assistant Professor","100625144",false,"NCT07418814","Infant Massage for Lymphedema and Comfort in Preterm Newborns","The Effectiveness of Infant Massage in Reducing Immobilization-Related Lymphedema Symptoms and Increasing Comfort in Preterm Newborns","Inclusion Criteria:\n\nTo ensure a homogenous and clinically stable sample, infants meeting the following criteria will be recruited:\n\n* Clinical diagnosis of lymphedema.\n* Hemodynamic and clinical stability.\n* No current or recent (within 24 hours) administration of analgesic or sedative medications that could mask comfort assessments.\n* Intact skin integrity with no contraindications for topical massage.\n* Absence of congenital heart disease or neurological disorders (antenatal or postnatal diagnosis).\n* No immediate requirement for endotracheal aspiration.\n* Requirement for only non-invasive respiratory support (e.g., nCPAP).\n* Provision of written informed consent by the legal guardians (parents).\n\nExclusion Criteria:\n\nInfants will be excluded if they present with:\n\n* Major congenital anomalies.\n* Severe respiratory, cardiac, or neurological instability during the study period.\n* Any acute medical contraindication identified by the attending neonatologist.","ALL","28 Weeks","37 Weeks",{"count":48,"type":49},40,"ESTIMATED","INTERVENTIONAL",[52],"NA","This randomized controlled trial investigates the effectiveness of infant massage in reducing symptoms of immobilization-related lymphedema and improving comfort in preterm newborns hospitalized in the Neonatal Intensive Care Unit (NICU). Preterm infants frequently develop lymphedema due to their immature circulatory systems and prolonged lack of movement.\n\nThe study compares two groups of infants: one receiving standard care and another receiving a daily 15-minute massage therapy session for 14 consecutive days in addition to standard care. Researchers will evaluate the impact of the massage by measuring the circumference of the infants' wrists, elbows, ankles, and knees to assess fluid reduction. Additionally, the infants' comfort levels will be assessed using the Premature Infant Comfort Scale (PICS). The goal is to determine if massage can serve as a safe, non-invasive method to manage lymphedema and reduce distress in this vulnerable population.",[55,56,57,58],"Lymphedema","Premature Birth","Edema","Immobilization",[60,61,55,62,63,58],"Infant Massage","Preterm Infant","Neonatal Comfort","Massage Therapy","NOT_YET_RECRUITING","2026-02-11",{"date":67,"type":68},"2026-02-18","ACTUAL",{"date":70,"type":49},"2026-04-01",{"date":72,"type":49},"2027-04-01",{"name":5,"class":6}]