[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548477":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":18,"responsibleParty":36,"collaborators":38,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":18,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":18,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":18,"overallStatus":63,"whyStopped":18,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":18},{"fullName":5,"class":6},"King's College Hospital NHS Trust","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Neonates given LISA during HFNC treatment","EXPERIMENTAL","Infants between 34-38+6 weeks gestation will receive surfactant via less invasive administration whilst on high flow nasal cannula oxygen treatment. They will have respiratory function monitoring before and after LISA.",[13],"Procedure: Less invasive surfactant administration during high flow nasal cannula treatment",{"label":15,"type":16,"description":17,"interventionNames":18},"Neonates not given LISA","NO_INTERVENTION","Infants between 34-38+6 will receive routine care and will not receive surfactant unless intubated.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","Less invasive surfactant administration during high flow nasal cannula treatment","Surfactant distilled through a small tube inserted into the windpipe via the mouth whilst the baby is awake and supported with HFNC.",[9],[26],{"name":27,"affiliation":28,"role":29},"Theodore Dassios, PHD","King's College London","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Eleanor Jeffreys, MBBS","CONTACT","+447519 974813","eleanor.jeffreys@nhs.net",{"type":37,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[39],{"name":40,"class":41},"Chiesi Limited","UNKNOWN","100548477","less-invasive-surfactant-administration-in-late-preterm-or-early-term-born-infants-100548477",false,"NCT06421506","Less Invasive Surfactant Administration in Late Preterm or Early Term Born Infants","Does Less Invasive Surfactant Administration (LISA) During High-flow Nasal Cannula Oxygen Treatment Reduces the Need for Invasive Ventilation in Late Preterm and Term Born Infants With Respiratory Distress?","Inclusion Criteria:\n\n* Infants born at 34+0 to 38+6 weeks of gestation, requiring resuscitation at birth, but who achieve regular spontaneous breathing and have a heart rate over 100 beats per minute while receiving non-invasive support.\n* Infants enrolled in the Surfon trial, born at 34+0 to 38+6 weeks of gestation, who are less than or equal to 24 hours old and exhibit signs of respiratory distress, defined as an FiO2 greater or equal to 0.30 but less than 0.45 needed to maintain an SpO2 greater than or equal to 92% or a clinically significant work of breathing regardless of the FiO2 and a clinical decision to provide non-invasive respiratory support.\n\nExclusion Criteria:\n\n* Infants requiring intubation at birth\n* Infants with severe congenital anomalies.","ALL","34 Weeks","38 Weeks",{"count":53,"type":54},245,"ESTIMATED","INTERVENTIONAL",[57],"NA","The aim of this study is to see if giving less invasive surfactant administration (LISA) during high-flow nasal cannula (HFNC) oxygen treatment reduces the need for invasive ventilation in babies with breathing problems born 2-6 weeks early.\n\nLess invasive surfactant administration is where surfactant (a naturally produced substance which helps open up the tiny air sacs in the lungs making it easier for babies to breathe) is given into the lungs by putting a small tube into the windpipe through the mouth whilst the baby is awake. The surfactant is given slowly and breathed in.\n\nHigh flow nasal cannula is a form of non-invasive support where a machine delivers warmed, moist oxygen and air through short tubes in the nose.\n\nThe investigators will be assessing whether a lower percentage of neonates need invasive ventilation within 72 hrs from birth when they have had LISA during HFNC treatment, compared to when they don't receive this treatment.\n\nThe investigators will also be looking at the length of neonatal unit stay and the cost of the stay. The investigators will also be measuring the lung function of the babies before and after they receive LISA.",[60,61,62],"Respiratory Distress Syndrome","Preterm Pregnancy","Surfactant Deficiency Syndrome Neonatal","NOT_YET_RECRUITING","2024-05-21",{"date":66,"type":67},"2024-05-22","ACTUAL",{"date":69,"type":54},"2024-05",{"date":71,"type":54},"2026-09",{"name":5,"class":6}]