[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525546":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":101,"collaborators":104,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":18,"maxAge":116,"enrollmentInfo":117,"targetDuration":18,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"University of California, San Diego","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standardized NIS Wean","EXPERIMENTAL","A standardized maintenance\u002Fweaning protocol will be implemented for the treatment group (standardized NIS wean). All infants in the treatment group will remain on NIS until either 32 or 34 weeks CGA, depending on their gestational age at birth. Infants born at 27 6\u002F7 weeks or less will continue on NIS until at least 34 weeks if they are in the treatment group, whereas infants born between 28 0\u002F7 and 29 6\u002F7 weeks will stay on NIS until at least 32 weeks if they are in the treatment group. The weaning protocol in the treatment group will incorporate algorithms outlining stability criteria, failure criteria, and algorithms for registered nurses (RNs) and respiratory therapists (RTs), including steps to take in such situations. The control group will be weaned according to the unit's or medical team's practices.",[13],"Other: Standardized\u002Fstructured CPAP weaning protocol",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Babies in the control group (non-standardized wean) will be weaned based on unit specific practices.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Standardized\u002Fstructured CPAP weaning protocol","Standardized\u002Fstructured CPAP weaning protocol up to 32 or 34 weeks gestational age (GA) (based on GA at birth) for infants born at less than 30 weeks GA.",[9],[25],{"name":26,"affiliation":5,"role":27},"Sandra Leibel, MD","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":18,"email":32},"CONTACT","858-249-1702","saleibel@health.ucsd.edu",{"name":34,"role":30,"phone":35,"phoneExt":18,"email":36},"Sarah Lazar, MPH","858-249-1711","slazar@health.ucsd.edu",[38,55,67,75,87],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Palomar Medical Center Rady NICU","RECRUITING","Escondido","California","92029","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-117.08642,33.11921,{"lat":50,"lon":49},[53,54],{"name":26,"role":30,"phone":31,"phoneExt":18,"email":32},{"name":34,"role":30,"phone":35,"phoneExt":18,"email":36},{"facility":56,"status":40,"city":57,"state":42,"zip":58,"country":44,"countryCode":45,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Scripps La Jolla Rady NICU","La Jolla","92037",{"type":47,"coordinates":60},[61,62],-117.2742,32.84727,{"lat":62,"lon":61},[65,66],{"name":26,"role":30,"phone":18,"phoneExt":18,"email":32},{"name":34,"role":30,"phone":35,"phoneExt":18,"email":36},{"facility":68,"status":40,"city":57,"state":42,"zip":58,"country":44,"countryCode":45,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"University of California, San Diego Jacobs Medical Center",{"type":47,"coordinates":70},[61,62],{"lat":62,"lon":61},[73,74],{"name":26,"role":30,"phone":18,"phoneExt":18,"email":32},{"name":34,"role":30,"phone":35,"phoneExt":18,"email":36},{"facility":76,"status":40,"city":77,"state":42,"zip":78,"country":44,"countryCode":45,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Rancho Springs Medical Center Rady NICU","Murrieta","92562",{"type":47,"coordinates":80},[81,82],-117.21392,33.55391,{"lat":82,"lon":81},[85,86],{"name":26,"role":30,"phone":18,"phoneExt":18,"email":32},{"name":34,"role":30,"phone":35,"phoneExt":18,"email":36},{"facility":88,"status":40,"city":89,"state":42,"zip":90,"country":44,"countryCode":45,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Rady Children's Hospital-San Diego","San Diego","92123",{"type":47,"coordinates":92},[93,94],-117.16472,32.71571,{"lat":94,"lon":93},[97,98],{"name":26,"role":30,"phone":18,"phoneExt":18,"email":32},{"name":34,"role":30,"phone":99,"phoneExt":100,"email":36},"858-576-1700","223209",{"type":27,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Sandra Leibel","Associate Clinical Professor",[105],{"name":106,"class":6},"Rady Children's Hospital, San Diego","100525546","flow-and-grow---the-ideal-time-to-wean-cpap-off-in-extremely-low-birth-weight-infants-100525546",false,"NCT06123143","Flow and Grow - The Ideal Time to Wean CPAP Off In Extremely Low Birth Weight Infants","Flow and Grow - A CPAP Management Strategy for Preterm Infants to Support Lung Growth. A Randomized, Prospective, Multi-center Study","Flow&Grow","Inclusion Criteria:\n\n1. All infants admitted to the NICU at Jacobs, Rancho Springs, Scripps La Jolla, Rady Children's Hospital, or Palomar born at \\\u003C 30 weeks CGA\n2. Informed parental consent obtained\n\nExclusion Criteria:\n\n1. Declined or unable to give informed consent\n2. Infants with known congenital anomalies or complications that require long term support (pulmonary hypoplasia, airway defects, genetic syndromes, necrotizing enterocolitis (NEC), spontaneous intestinal perforation (SIP), anything surgical)\n3. Intubated for over 4 weeks of life (28 days)","ALL","30 Weeks",{"count":118,"type":119},130,"ESTIMATED","INTERVENTIONAL",[122],"NA","Preterm neonates born at less than 30 weeks' gestation are commonly maintained on invasive or non-invasive respiratory support to facilitate gas exchange. While non-invasive respiratory support (NIS) can be gradually reduced over time as the infant grows, most weaning strategies often lead to weaning failure. This failure is evidenced by an increase in significant events such as apneas, desaturations, and\u002For bradycardias, increased work of breathing, or an inability to oxygenate or ventilate, resulting in escalated respiratory support. Although the optimal approach to weaning NIS remains uncertain, neonatal units that delay Continuous Positive Airway Pressure (CPAP) weaning until 32-34 weeks corrected gestational age exhibit lower rates of chronic lung disease. Therefore, the investigators aim to compare the duration on respiratory support and oxygen exposure in infants born at less than 30 weeks' gestational age who undergo a structured weaning protocol that includes remaining on CPAP until at least 32-34 weeks corrected gestational age (CGA). The hypothesis posits that preterm infants following a structured weaning protocol, including maintaining CPAP until a specific gestational age, will demonstrate lower rates of weaning failure off CPAP (defined as requiring more support and\u002For experiencing increased stimulation events 72 hours after CPAP weaning) than those managed according to the medical team's discretion.",[125],"Neonatal Respiratory Failure",[127,128],"Neonatal","CPAP","2026-01-15",{"date":131,"type":132},"2026-01-20","ACTUAL",{"date":134,"type":132},"2023-11-27",{"date":136,"type":119},"2028-11",{"name":5,"class":6},5]