[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623397":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":26,"centralContacts":35,"locations":47,"responsibleParty":70,"collaborators":72,"id":75,"slug":26,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":26,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":26,"maxAge":83,"enrollmentInfo":84,"targetDuration":26,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":26,"overallStatus":62,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"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",[48,60],{"facility":49,"status":50,"city":51,"state":52,"zip":26,"country":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":26},"Clinica San Carlos de Apoquindo","ACTIVE_NOT_RECRUITING","Santiago","Santiago Metropolitan","Chile",{"type":55,"coordinates":56},"Point",[57,58],-70.64827,-33.45694,{"lat":58,"lon":57},{"facility":61,"status":62,"city":51,"state":52,"zip":26,"country":53,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"UC Christus Clinical Hospital","RECRUITING",{"type":55,"coordinates":64},[57,58],{"lat":58,"lon":57},[67],{"name":68,"role":38,"phone":69,"phoneExt":26,"email":41},"Paulina Toso, MD","+56993459661",{"type":71,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[73],{"name":74,"class":6},"Agencia Nacional de Investigación y Desarrollo","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":85,"type":86},20,"ESTIMATED","INTERVENTIONAL",[89],"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.",[92,93,94],"Preterm","Apnea of Prematurity","Hypoxemia","2026-02-03",{"date":97,"type":98},"2026-02-09","ACTUAL",{"date":100,"type":98},"2024-09-01",{"date":102,"type":86},"2026-05-31",{"name":5,"class":6},2]