[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597618":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":43,"centralContacts":47,"locations":54,"responsibleParty":77,"collaborators":80,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":10,"studyType":97,"phases":10,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":57,"whyStopped":10,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase I: 15 preterm infants on Bubble Continuous Positive Airway Pressure (bCPAP)",null,"Group 1 will consist of 15 preterm infants on bCPAP in whom the external bubble CPAP sounds and the pressures from the CPAP system itself will be recorded for 3 hours. To do so, we will use a standard microphone placed on the water tank and an external pressure transducer inserted into the expiratory limb of the bubble CPAP circuit.",[13,14],"Device: External pressure transducer","Device: Standard microphone",{"label":16,"type":10,"description":17,"interventionNames":18},"Phase II: 15 preterm infants on Bubble Continuous Positive Airway Pressure (bCPAP)","Group 2 will consist of 15 preterm infants on bCPAP in whom the external bubble CPAP sounds and the pressures from the CPAP system itself will be recorded. To do so, we will use a standard microphone placed on the water tank and a pressure transducer inserted into the expiratory limb of the bubble CPAP circuit. In addition, the internal bubble CPAP sound and pressure transmitted to the infant's lungs will be measured. For these, a wireless acoustic sensor will be secured on the infant's suprasternal notch to capture transmitted CPAP sounds, and an internal pressure transducer will be inserted from the infant's mouth into the nasopharynx to record the pressure delivered in the airway. Data will be recorded for 3 hours.",[13,14,19,20],"Device: Wireless acoustic sensor","Device: Internal pressure transducer",[22,29,35,39],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","External pressure transducer","The delivered CPAP pressure will be measured using an ultra-thin, multi-use catheter pressure transducer inserted into a port in the expiratory limb of the bubble CPAP circuit.",[9,16],[28],"External catheter pressure transducer (Millar Mikro-tip ® SPR-524, 3.5F Single straight, Texas)",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Standard microphone","The bubble sound of the water tank will be collected with a standard condenser microphone directly affixed to the pole holding the water tank, with a secure clip.",[9,16],[34],"Lavalier condenser microphone, Tosuny",{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":10},"Wireless acoustic sensor","The wireless acoustic sensor contains a dual microphone capable of capturing target sounds as well as ambient noise. The frequencies associated with ambient noise will be subtracted to maximize the signal-to-noise ratio of the bubble sound waveform. The wireless sensor will be placed on the suprasternal notch of the infant for monitoring the bubble sounds transmitted to the lungs and secured using a silicone-based tape approved for use in neonates. Data will be transmitted in real-time to a research-dedicated tablet using the Bluetooth Communication Controller and stored for future analysis.",[16],{"type":23,"name":40,"description":41,"armGroupLabels":42,"otherNames":10},"Internal pressure transducer","The transmitted CPAP pressure will be measured using an ultra-thin, single-use catheter pressure transducer inserted through the mouth to the level of the infant's nasopharynx. The data will be acquired with a sampling rate of 10kHz and stored for later analysis.",[16],[44],{"name":45,"affiliation":5,"role":46},"Wissam Shalish, MD PhD","PRINCIPAL_INVESTIGATOR",[48],{"name":49,"role":50,"phone":51,"phoneExt":52,"email":53},"Wissam Shalish, MD, PhD","CONTACT","514-412-4400","22341","wissam.shalish@mcgill.ca",[55],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"McGill University Health Center","RECRUITING","Montreal","Quebec","H4A 3J1","Canada","CA",{"type":64,"coordinates":65},"Point",[66,67],-73.58781,45.50884,{"lat":67,"lon":66},[70,71,72,75],{"name":49,"role":50,"phone":51,"phoneExt":52,"email":53},{"name":45,"role":46,"phone":10,"phoneExt":10,"email":10},{"name":73,"role":74,"phone":10,"phoneExt":10,"email":10},"Guilherme Sant'Anna, MD PhD","SUB_INVESTIGATOR",{"name":76,"role":74,"phone":10,"phoneExt":10,"email":10},"Robert Kearney, MD PhD",{"type":46,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Wissam Shalish","Assistant Professor",[81],{"name":82,"class":6},"Northwestern University","100597618","acoustics-as-a-metric-of-airway-pressure-in-premature-infants-using-bubble-continuous-positive-airway-pressure-100597618",false,"NCT07060833","Acoustics as a Metric of Airway Pressure in Premature Infants Using Bubble Continuous Positive Airway Pressure","The Use of Bubble Continuous Positive Airway Pressure in Premature Infants: Acoustics as a Metric of Effective Pressure Delivery","Bubble CPAP","Inclusion Criteria:\n\n* Infants on bCPAP with gestational age \\\u003C 32+0 weeks\n* Postmenstrual age between 28+0 and 36+6 weeks at the time of the study\n* Postnatal age greater than 168 hours (7 days) at the time of the study\n* On the bubble CPAP device with binasal prongs at the time of the study\n* Receiving bubble CPAP levels of 5 to 7 cm H2O with gas flows between 6L\u002Fmin and 10L\u002Fmin at the time of the study\n\nExclusion Criteria:\n\n* Infants with known major congenital anomalies\n* Infants with known congenital heart disorders\n* Infants with known neuromuscular disease\n* Infants receiving ventilator-derived CPAP at the time of the study\n* Infants receiving CPAP via a nasal mask interface at the time of the study\n* Infants receiving inotropes, narcotics or sedative agents at the time of the study\n* Infants deemed clinically unstable for the study by the attending neonatologist","ALL","28 Weeks","32 Weeks",{"count":95,"type":96},30,"ESTIMATED","OBSERVATIONAL","This is an observational, proof-of-concept, feasibility study where 30 preterm infants on bubble CPAP with gestational age \\\u003C 32+0 weeks will be recruited from the neonatal intensive care unit (NICU) at the Montreal Children's Hospital.\n\nThe study's main goals are:\n\n1. To determine the relationship between ambient bubbling sounds and delivered pressures in preterm infants on bCPAP.\n2. To determine the relationship between transmitted bubbling sounds and airway pressures transmitted to the lungs of preterm infants on bCPAP.\n3. To develop models to predict delivered and transmitted bCPAP pressures from the acoustic properties of bubbling sounds.",[100],"Preterm Infant",[89,102,103,104,105,106,107],"Airflow","Neonatal Intensive Care","Respiratory acoustics","Acoustic monitoring","Airway pressure monitoring","Bubbling sounds","2026-03-24",{"date":110,"type":111},"2026-03-30","ACTUAL",{"date":113,"type":111},"2025-04-03",{"date":115,"type":96},"2026-12",{"name":5,"class":6},1]