[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558932":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":28,"locations":34,"responsibleParty":52,"collaborators":18,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":18,"maxAge":62,"enrollmentInfo":63,"targetDuration":18,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":18,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"University College Dublin","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Thin catheter surfactant","EXPERIMENTAL","At or after 5 minutes of life, participants will have a thin endotracheal catheter (Surfcath, Vygon, Ecouen, France) inserted under video laryngoscopy (C-MAC, Karl Storz, Tuttlingen, Germany), through which they will receive surfactant (Curosurf, Chiesi Farmaceutici, Parma, Italy - 120mg for infants \\\u003C 26 weeks, 240mg for infants 26 - 27+6 weeks). The catheter will then be removed, and they will continue on face mask breathing support.",[13],"Other: Thin catheter surfactant",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard care","NO_INTERVENTION","Participants will continue on face mask breathing support.",null,[20],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":18},"Surfactant given through thin catheter inserted under video laryngoscopy at or after 5 minutes of life",[9],[24],{"name":25,"affiliation":26,"role":27},"Colm PF O'Donnell","National Maternity Hospital, University College Dublin","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},"Colm PF O'Donnell, MB PhD","CONTACT","35316373100","codonnell@nmh.ie",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"National Maternity Hospital","RECRUITING","Dublin","None Selected","D02 YH21","Ireland","IE",{"type":44,"coordinates":45},"Point",[46,47],-6.24889,53.33306,{"lat":47,"lon":46},[50],{"name":51,"role":31,"phone":32,"phoneExt":18,"email":33},"Colm PF O'Donnell, MB PhD",{"type":53,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100558932","prophylactic-surfactant-by-thin-endotracheal-catheter-for-preterm-infants-at-birth-the-protect-trial-100558932",false,"NCT06557551","Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants At Birth: the ProTeCt Trial","proTeCt","Inclusion criteria\n\n* Infants of any sex born before 28 weeks of gestation\n* Clinicians plan to provide intensive care\n* Consent for their participation provided by parent(s)\u002Fguardian(s) before their birth\n\nExclusion criteria\n\n• Major congenital anomalies (e.g. upper airway anomaly, diaphragmatic hernia, gastroschisis, exomphalos major, intestinal atresias, open neural tube defect, aneuploidy, cardiac lesions other than ASD\u002FPFO\u002FVSD\u002FPDA )","ALL","30 Minutes",{"count":64,"type":65},164,"ESTIMATED","INTERVENTIONAL",[68],"NA","The goal of this clinical trial is to learn whether giving surfactant through a thin endotracheal catheter to extremely premature babies shortly after birth reduces the number of them who are ventilated in the first 3 days of life.\n\nThe main question it aims to answer is:\n\nDo fewer babies who receive prophylactic thin catheter surfactant under video laryngoscopy shortly after birth go on to be ventilated within 72 hours of birth?\n\nExtremely premature babies who are receiving breathing support through a face mask will either:\n\n* Receive surfactant through a thin catheter that is inserted into their windpipe (trachea) under video laryngoscopy at or after 5 minutes of life, have the catheter removed immediately, and return to face mask breathing support; or\n* Continue on face mask breathing support.\n\nAll babies will be closely watched to see whether they are ventilated for breathing support in the first 72 hours of life.",[71,72,73,74],"Infant, Newborn, Diseases","Prematurity","Prematurity; Extreme","Respiratory Distress Syndrome in Premature Infant","2024-10-08",{"date":77,"type":78},"2024-10-15","ACTUAL",{"date":80,"type":78},"2024-08-19",{"date":82,"type":65},"2027-02-28",{"name":5,"class":6},1]