[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659608":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":26,"studyPopulation":27,"armGroups":28,"interventions":34,"overallOfficials":11,"centralContacts":39,"locations":46,"responsibleParty":67,"collaborators":11,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":11,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":11,"studyType":82,"phases":11,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":93,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"King's College Hospital NHS Trust","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"The increase in respiratory resistance (R) in centimeters water per liter per second of participants who received automated oxygen control in the neonatal period compared to those who received manual oxygen control.",null,"From enrollment to the end of monitoring at one hour.",{"measure":14,"description":11,"timeFrame":12},"The reduction in respiratory reactance (X) in centimeters water per liter per second of participants who received automated oxygen control in the neonatal period compared to those who received manual oxygen control.",[16,19,21],{"measure":17,"description":11,"timeFrame":18},"To evaluate differences in the frequency of episodes of breathing difficulties (number of episodes per month) after discharge from neonatal care with the use of parent-questionnaires.","From enrolment to the end of monitoring at one hour.",{"measure":20,"description":11,"timeFrame":12},"To evaluate differences in the absolute number of courses of antibiotics given for respiratory infections after discharge from neonatal care with the use of parent-questionnaires.",{"measure":22,"description":11,"timeFrame":12},"To evaluate differences in the absolute number of hospital readmissions after discharge from neonatal care with the use of parent-questionnaires.",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":24,"timePerspective":25,"maskingInfo":11},"COHORT","PROSPECTIVE","Eligible infants will be identified from the recruitment log of the study 'Optimising ventilation in preterms with closed-loop oxygen control' (IRAS: 297749). These children were born between September 2021 and February 2025. Parents of all survivors will be approached via a phone call and\u002F or email by the investigators. The parents will be provided with an information sheet about the study via email. The researchers will answer questions over the phone\u002F via email and face-to-face during the appointment. Written informed consent will be obtained.\n\nThe children will be asked to attend the outpatient department at King's College Hospital when clinically well and without respiratory tract infections in the previous four weeks.\n\nDemographic information will be obtained from the children's medical records including gestational age, birth weight, antenatal steroids, administration of surfactant, duration of mechanical ventilation and oxygen treatment, postnatal steroids, diagnosis of bronchopulmonary dysplasia, that is a chronic lung disease, and need for home oxygen.\n\nBody weight and height at the time of testing will be measured and recorded. The Thorasys Tremoflo-C100 Airwave Oscillometry System TM (Thorasys, Montreal, QC, Canada) will be used with Thorasys software for children at or above two years of age. The device will measure lung resistance and reactance (compliance) at specific frequencies.\n\nPatients will be assessed in a seated position with a nose clip in place and the investigator will support their cheeks and lower jaw. Children who cannot tolerate the nose clip will have their nose held by their accompanying parent\u002Fguardian. The participants will be breathing through a standard mouthpiece filter. Forced oscillometry testing will be performed for 20 seconds. Measurements will be repeated until a minimum of three valid tests is obtained. The mean results of at least two adequate measurements will be used for analysis.\n\nFor infants less than two years of age the TremoFlo N-100 Airwave Oscillometry System (Thorasys Thoracic Medical Systems Inc. Montreal, Quebec, Canada) will be used. The infants will be placed in supine position and will be breathing via a cushioned face mask covering the nose and mouth and a filter (Humid-Vent Filter Small, Teleflex Medical, Ireland). Measurements will be performed at the same frequencies as the older children.\n\nParents will be invited to fill in a questionnaire related to their child's health following discharge from the neonatal unit. This will include questions about duration of home oxygen treatment, frequency of breathing difficulties, any respiratory infections requiring antibiotics, hospital admissions and their reasons, and presence of smokers in the household.\n\nAll measurements will be completed during a single clinic visit on the same day and no follow up will be required.","Preterm-born children requiring mechanical ventilation at birth who participated in a randomised controlled trial of automated versus manual oxygen control.",[29],{"label":30,"type":11,"description":31,"interventionNames":32},"Preterm-born children at one to five years of age","Preterm-born children \\\u003C34 weeks gestation that participated in a randomised controlled trial of automated versus manual oxygen control in the early neonatal period will be included in the study. Lung mechanics will be measured via forced oscillometry technique at follow up.",[33],"Other: Forced oscillometry technique",[35],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":11},"Forced oscillometry technique","Patients will be assessed in a seated position with a nose clip in place and the investigator will support their cheeks and lower jaw. Children who cannot tolerate the nose clip will have their nose held by their accompanying parent\u002Fguardian. The participants will be breathing through a standard mouthpiece filter. Each FOT will be performed for 20 seconds. Testing will be repeated until a minimum of three tests is obtained with coherence of variance (CoV) equal or less than 15% at R5. The mean results of at least two adequate measurements will be used for analysis.\n\nFor infants less than two years of age the TremoFlo N-100 Airwave Oscillometry System (Thorasys Thoracic Medical Systems Inc. Montreal, Quebec, Canada) will be used. The infants will be placed in supine position and will be breathing via a cushioned face mask covering the nose and mouth and a filter (Humid-Vent Filter Small, Teleflex Medical, Ireland). Measurements will be performed at the same frequencies.",[30],[40],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Ourania Kaltsogianni, MD (Res)","CONTACT","0044+02032999000","38494","ourania.kaltsogianni@nhs.net",[47],{"facility":48,"status":11,"city":49,"state":11,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"King's College Hospital NHS Foundation Trust","London","SE5 9RS","United Kingdom","UK",{"type":54,"coordinates":55},"Point",[56,57],-0.12574,51.50853,{"lat":57,"lon":56},[60,61,64],{"name":41,"role":42,"phone":44,"phoneExt":44,"email":45},{"name":62,"role":42,"phone":11,"phoneExt":11,"email":63},"Anne","anne.greenough@kcl.ac.uk",{"name":65,"role":66,"phone":11,"phoneExt":11,"email":11},"Anne Greenough, Professor","PRINCIPAL_INVESTIGATOR",{"type":68,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100659608","effect-of-automated-oxygen-control-on-early-childhood-lung-mechanics-100659608",false,"NCT07866820","Effect of Automated Oxygen Control on Early-childhood Lung Mechanics","Assessment of Early-childhood Lung Mechanics of Preterm-born Ventilated Infants That Received Automated or Manual Oxygen Control: a Single-centre Prospective Observational Study","Inclusion Criteria:\n\n* Preterm-born children \\\u003C34 weeks gestation that participated in a randomised controlled trial of automated versus manual oxygen control in the early neonatal period and:\n* survived to early childhood\n* do not require continuous non-invasive ventilation\n* do not have a tracheostomy.\n\nExclusion Criteria:\n\n* Infants excluded from the previous randomised trial\n* Infants who did not survive to early childhood\n* Survivors in need of continuous non-invasive ventilation\n* Survivors with a tracheostomy\n* Non-English speakers","ALL","1 Year","5 Years",{"count":80,"type":81},60,"ESTIMATED","OBSERVATIONAL","Preterm infants are at higher risk of long-term respiratory problems and abnormal lung function in childhood. Respiratory support including mechanical ventilation, that is the use of a machine to move air into and out of the lungs, and oxygen treatment may further increase the risk of complications. In a randomised controlled trial, closed-loop automated oxygen control (CLAC) was associated with reductions in the duration of mechanical ventilation and oxygen treatment and may, therefore, help reduce long-term respiratory morbidity.\n\nThe effect of CLAC systems on lung function has not been explored to date. This prospective observational study aims to explore the effect of automated oxygen control during the neonatal period on lung mechanics in children who were born at less than 34 weeks of gestation and required mechanical ventilation.\n\nThe study will take place at King's College Hospital (KCH) children's outpatient department. Parents of children that participated in the randomised trial of automated versus manual oxygen control will be approached, informed and if appropriate consented to join the study.\n\nThe study will measure outcomes including lung mechanics and parent-reported respiratory morbidity (breathing difficulties, respiratory infections, hospital admissions after discharge from neonatal care). Results will be compared between the two groups.\n\nLung mechanics will be assessed using a technique called forced oscillation. This is a technique which involves the patient breathing through a face mask (if less than two years of age) or a mouthpiece filter (if older than two years). It is a non-invasive technique that measures lung function by superimposing gentle air pressure waves onto the patient's spontaneous breathing.An average of three measurements each one lasting up to 20 seconds will be performed.\n\nParents will be asked to fill in a questionnaire regarding the health of their child after discharge from the neonatal unit.\n\nThe study's duration will be 12 months.",[85,86,87],"Prematurity","Respiratory Distress Neonatal","Oxygen Delivery",[89,90,91,92],"automated oxygen control","preterm infant","lung function","function oscillometry","NOT_YET_RECRUITING","2026-10-05",{"date":96,"type":97},"2026-10-08","ACTUAL",{"date":99,"type":81},"2026-10-12",{"date":101,"type":81},"2027-10-12",{"name":5,"class":6},1]