[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613704":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":25,"responsibleParty":35,"collaborators":37,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":25,"enrollmentInfo":50,"targetDuration":25,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":25,"overallStatus":59,"whyStopped":25,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":25},{"fullName":5,"class":6},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group Swaddy first","ACTIVE_COMPARATOR","In this project, patients will be randomized into two groups. In Group 1, on the first day (day 1), the first measurement (baseline) will be made. Subsequently, the Swaddy® containment device will be placed and the containment will be maintained for 3 hours, in which the same variables will be measured: Heart Rate (HR), Respiratory Rate (RF), temperature, O2 Saturation (SatO2) and pain scale at 60, 120 and 180 minutes. This procedure will be repeated on day 2 and 3. On day 4, the same measurements will be carried out using standard containment care. This procedure will be repeated on days 5 and 6 (all three at approximately the same time of day as in the intervention).",[13],"Device: Swaddy day 1, 2, 3",{"label":15,"type":10,"description":16,"interventionNames":17},"Group Swaddy second","In Group 2, on the first day (day 1), the first measurement (baseline) will be taken. Subsequently, the patient will be kept in an incubator for 3 hours, in which the following variables will be measured: Heart Rate (HR), Respiratory Rate (RF), temperature, O2 Saturation (SatO2) and pain scale at 60, 120 and 180 minutes, using standard containment care. This procedure will be repeated on day 2 and 3. On day 4, the same measurements will be carried out by applying containment with the Swaddy® device and will be repeated on days 5 and 6.",[18],"Device: Swaddy day 4, 5, 6",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Swaddy day 1, 2, 3","In Group 1, on the first day (day 1), the first measurement (baseline) will be made. Subsequently, the Swaddy® containment device will be placed and the containment will be maintained for 3 hours, in which the same variables will be measured: Heart Rate (HR), Respiratory Rate (RF), temperature, O2 Saturation (SatO2) and pain scale at 60, 120 and 180 minutes. This procedure will be repeated on day 2 and 3. On day 4, the same measurements will be carried out using standard containment care. This procedure will be repeated on days 5 and 6 (all three at approximately the same time of day as in the intervention).",[9],null,{"type":21,"name":27,"description":16,"armGroupLabels":28,"otherNames":25},"Swaddy day 4, 5, 6",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Silvia VICENTE PÉREZ, Principal Investigator","CONTACT","+34 647531247","svicente@santpau.cat",{"type":36,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[38],{"name":39,"class":6},"Fundació Institut Germans Trias i Pujol","100613704","swaddy-a-neonatal-positioning-device-100613704",false,"NCT07270055","Swaddy, a Neonatal Positioning Device.","Effect of Neonatal Device Swaddy® on the Stress Level of Preterm Newborns: A Randomized Clinical Trial.","Swaddy","Inclusion Criteria:\n\n* Newborns weighing ≤1500 grams at birth admitted to the NICU. • Patients who are in an incubator.\n\nExclusion Criteria:\n\n* Hemodynamic instability.\n\n  * Be a carrier of CPAP or nasal BIPAP with a cap (because the CPAP\u002FBIPAP already has a built-in cap, just like Swaddy).\n  * Be in treatment with phototherapy.","ALL","3 Days",{"count":51,"type":52},56,"ESTIMATED","INTERVENTIONAL",[55],"NA","The objective of this clinical trial is to evaluate the effect of positional restraint on the stress level of preterm newborns, resting in the incubator. The main question sought to be answered is: The stress level of the preterm newborn will decrease with swaddy® containment, compared to standard care, and both with similar safety.\n\nParticipants will remain in the incubator for 3 consecutive hours and the level of stress in the same patient will be evaluated, one day with containment and another day without containment.",[58],"Stress","NOT_YET_RECRUITING","2025-12-04",{"date":62,"type":63},"2025-12-08","ACTUAL",{"date":65,"type":52},"2025-12",{"date":67,"type":52},"2027-12",{"name":5,"class":6}]