[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657246":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":24,"studyPopulation":17,"armGroups":25,"interventions":38,"overallOfficials":17,"centralContacts":48,"locations":54,"responsibleParty":72,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":17,"eligibilityCriteria":83,"healthyVolunteers":80,"sex":84,"minAge":17,"maxAge":85,"enrollmentInfo":86,"targetDuration":17,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":98,"overallStatus":102,"whyStopped":17,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Sharp HealthCare","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Parent perception of different respiratory devices","To assess parent perception of different respiratory devices, namely the OptiPAP Junior, in comparison to other modalities through semi-structured parent interviews.","From baseline to study completion, an average of 3 months.",[14],{"measure":15,"description":16,"timeFrame":12},"Parent perception and recommendations on inpatient pulmonary support and outcome measurements","To detail family member perception of lung disease and respiratory support, parent recommendations of how to improve NICU bonding in setting of respiratory needs, and parent recommendations on inpatient pulmonary outcome measurements through semi-structured parent interviews.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"RANDOMIZED","CROSSOVER","SUPPORTIVE_CARE",{"masking":23,"maskingDescription":17,"whoMasked":17},"NONE","The information gathered in this study is relevant to all NICU families of children who need respiratory support as the investigators will assess parent perceptions of different devices, namely the OptiPAP Junior, as well as aspects of respiratory support to share with the broader NICU community and change how NICU providers talk about these devices and lung outcomes with parents.",[26,32],{"label":27,"type":28,"description":29,"interventionNames":30},"OptiPAP Junior","EXPERIMENTAL","The OptiPAP Junior device (Fisher \\& Paykel) is an FDA cleared device interface for the provision of pressure-based respiratory support to be used in accordance with its approved labeling.",[31],"Device: Nasal CPAP interface: OptiPAP Junior",{"label":33,"type":34,"description":35,"interventionNames":36},"Flexitrunk","ACTIVE_COMPARATOR","The Flexitrunk (Fisher \\& Paykel) is a predominant interface used in neonatal care units. Flexitrunk is an FDA cleared device interface for the provision of pressure-based respiratory support to be used in accordance with its approved labeling.",[37],"Device: Nasal CPAP interface: FlexiTrunk",[39,44],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":17},"DEVICE","Nasal CPAP interface: OptiPAP Junior","FDA 510(k)-cleared non-invasive nasal interface used to deliver continuous positive airway pressure. Infants receive CPAP via the OptiPAP Junior interface for 5 consecutive days, either as the first or second interface depending on randomized sequence. CPAP level and duration are managed by the clinical team per standard NICU practice; the device is used in accordance with its cleared labeling",[27],{"type":40,"name":45,"description":46,"armGroupLabels":47,"otherNames":17},"Nasal CPAP interface: FlexiTrunk","FDA-cleared Class I, 510(k)-exempt nasal interface that is the standard CPAP interface in many neonatal care units. Infants receive CPAP via the FlexiTrunk interface for 5 consecutive days, either as the first or second interface depending on randomized sequence. CPAP level and duration are managed by the clinical team per standard NICU practice.",[33],[49],{"name":50,"role":51,"phone":52,"phoneExt":17,"email":53},"Rebecca Dorner, MD, MHS","CONTACT","858-939-4391","Rebecca.Dorner@sharp.com",[55],{"facility":56,"status":17,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Sharp Mary Birch Hospital for Women & Newborns","San Diego","California","92123","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-117.16472,32.71571,{"lat":66,"lon":65},[69,70],{"name":50,"role":51,"phone":52,"phoneExt":17,"email":53},{"name":50,"role":71,"phone":17,"phoneExt":17,"email":17},"PRINCIPAL_INVESTIGATOR",{"type":71,"investigatorFullName":50,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Principal Investigator",[75],{"name":76,"class":77},"Fisher & Paykel","UNKNOWN","100657246","parent-perceptions-of-optipap-junior-100657246",false,"NCT07837700","Parent Perceptions of OptiPAP Junior","Inclusion Criteria:\n\n* Infants born less than 31 weeks who have been stable for 72 hours on continuous positive pressure level (CPAP) of support via a standard interface.\n* Parents (females or males) must be greater than 18 years of age at the time of the interview after their infant has experienced both respiratory modalities.\n\nExclusion Criteria:\n\n* Infants will be excluded if they have suspected or confirmed abnormalities\u002Ftrauma to the skull or airway involving any abnormal connection that may allow pressure to be transmitted to unintended anatomical structures or tissues.","ALL","30 Weeks",{"count":87,"type":88},60,"ESTIMATED","INTERVENTIONAL",[91],"NA","To evaluate how different forms of respiratory support affect parent interaction, how parents feel about different methods of support, and how their child's current respiratory support level is perceived in the setting of long-term outcomes.",[94,95,96,97],"Bronchopulmonary Dysplasia (BPD)","Preterm Birth Complication","Pulmonary","CPAP",[99,100,101],"parent perception","NICU","respiratory support","NOT_YET_RECRUITING","2026-09-17",{"date":105,"type":106},"2026-09-23","ACTUAL",{"date":108,"type":88},"2026-10",{"date":110,"type":88},"2027-12",{"name":5,"class":6},1]