[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623397":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":26,"centralContacts":35,"locations":47,"responsibleParty":71,"collaborators":73,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":26,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":26,"maxAge":85,"enrollmentInfo":86,"targetDuration":26,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":26,"overallStatus":63,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Pontificia Universidad Catolica de Chile","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"PIMUN","ACTIVE_COMPARATOR","48 hours of dorsal stimulation by PIMUN. Continous cardiorespiratory monitorization- Brain NIRS first 24 hours- 4-5 hours of Polysomnogram at the second day. Blood and urine samples at the finish.",[13,14,15],"Other: Brain NIRS","Other: Polysomnogram","Other: Reactive oxydative species",{"label":17,"type":18,"description":19,"interventionNames":20},"48 hours without PIMUN","SHAM_COMPARATOR","48 hours without PIMUN. Continous cardiorespiratory monitorization- Brain NIRS first 24 hours- 4-5 hours of Polysomnogram at the second day. Blood and urine samples at the finish.",[13,14,15],[22,27,31],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"Brain NIRS","24 hours of Brain regional oxygen saturation by NIRS",[17,9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Polysomnogram","4-5 hours of polysomnogram recording",[17,9],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Reactive oxydative species","Blood and urine samples to detect plasma not albumin bound proteins- neuroprostane and isoflurane",[17,9],[36,42],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Paulina A Toso, MD","CONTACT","56223543349","3349","ptoso@med.puc.cl",{"name":43,"role":38,"phone":44,"phoneExt":45,"email":46},"Alvaro J González, MD","56223543224","3224","alvgonza@med.puc.cl",[48,61],{"facility":49,"status":50,"city":51,"state":52,"zip":26,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":26},"Clinica San Carlos de Apoquindo","ACTIVE_NOT_RECRUITING","Santiago","Santiago Metropolitan","Chile","CL",{"type":56,"coordinates":57},"Point",[58,59],-70.64827,-33.45694,{"lat":59,"lon":58},{"facility":62,"status":63,"city":51,"state":52,"zip":26,"country":53,"countryCode":54,"cosmosGeoPoint":64,"geoPoint":66,"contacts":67},"UC Christus Clinical Hospital","RECRUITING",{"type":56,"coordinates":65},[58,59],{"lat":59,"lon":58},[68],{"name":69,"role":38,"phone":70,"phoneExt":26,"email":41},"Paulina Toso, MD","+56993459661",{"type":72,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[74],{"name":75,"class":6},"Agencia Nacional de Investigación y Desarrollo","100623397","efficacy-of-pimun-by-reducing-intermittent-hypoxia-events-100623397",false,"NCT07396103","Efficacy of PIMUN by Reducing Intermittent Hypoxia Events","Clinical Study of Intermittent Hypoxia Reduction Using PIMUN: Efficacy Proof-of-Concept","Inclusion Criteria:\n\n* Preterm infants with a gestational age at birth \\\u003C34 weeks\n* Age \\\u003C30 days at the time of enrollment\n* Documented diagnosis of apnea of prematurity (AOP)\n\nExclusion Criteria:\n\n* Currently receiving mechanical ventilation (MV)\n* Presence of major congenital malformations\n* Clinically unstable or critically ill at the time of screening\n* Active sepsis or undergoing treatment for sepsis\n* Intraventricular hemorrhage (IVH) Grade \\> II\n* Receiving sedatives or anticonvulsant medications",true,"ALL","30 Days",{"count":87,"type":88},20,"ESTIMATED","INTERVENTIONAL",[91],"NA","The goal of this clinical trial is to learn if the use of PIMUN(medical device) works to reduce the intermittent hypoxemia of 24-34 weeks of birth gestational age babies. . It will also learn about the safety of the use of PIMUN. The main questions it aims to answer are:\n\nDoes PIMUN lower the time of oxygen saturation under 90%? What medical problems do participants have using PIMUN? Researchers will compare the use of PIMUN during 48 hours to 48 hours of usual treatments (not using PIMUN).\n\nParticipants will:\n\nUse\u002F or not use of PIMUN for a 48 hours period- randomly assigned. Regional brain oxygenation by near infrared spectroscopy (NIRS) monitoring at the first day of each 48 hours period. 4-6 hours of polysomnography at the second day of each intervention. Plasma and urine stress oxygen metabolites at the end of each 48-hours intervention.",[94,95,96],"Preterm","Apnea of Prematurity","Hypoxemia","2026-02-03",{"date":99,"type":100},"2026-02-09","ACTUAL",{"date":102,"type":100},"2024-09-01",{"date":104,"type":88},"2026-05-31",{"name":5,"class":6},2]