[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546908":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":41,"responsibleParty":68,"collaborators":18,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":18,"maxAge":18,"enrollmentInfo":79,"targetDuration":18,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":44,"whyStopped":18,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Semmelweis University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pre-extubational caffeine-citrate","ACTIVE_COMPARATOR","Participants will receive 20 mg\u002Fkg loading dose of caffeine citrate on the first day of life and after that 5-10 mg\u002Fkg maintenance dose each day. On this arm, the participants will receive 20 mg\u002Fkg caffeine dose once again before the planned extubation.",[13],"Drug: Caffeine citrate",{"label":15,"type":16,"description":17,"interventionNames":18},"Routine care","NO_INTERVENTION","Participants will receive 20 mg\u002Fkg loading dose of caffeine citrate on the first day of life and after that 5-10 mg\u002Fkg maintenance dose each day, also on the day of the extubation.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Caffeine citrate","20 mg\u002Fkg caffeine-citrate before the planned extubation.",[9],[26],"CITRATE DE CAFEINE COOPER 25 mg\u002Fml Coopération Pharmaceutique Française, Melun, France",[28],{"name":29,"affiliation":30,"role":31},"Ákos Gasparics, MD.PhD","Semmelweis University, Department of Obstetrics and Gynecology","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},"Kinga Kovács, MD.","CONTACT","+36206663718","kovacs.kinga1@semmelweis.hu",{"name":29,"role":35,"phone":39,"phoneExt":18,"email":40},"+36206663684","gasparics.akos@semmelweis.hu",[42,58],{"facility":43,"status":44,"city":45,"state":18,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Pediatric Center, Semmelweis University","RECRUITING","Budapest","1083","Hungary","HU",{"type":50,"coordinates":51},"Point",[52,53],19.04045,47.49835,{"lat":53,"lon":52},[56],{"name":57,"role":35,"phone":18,"phoneExt":18,"email":18},"Leina Mahdi, MD",{"facility":59,"status":44,"city":45,"state":18,"zip":60,"country":47,"countryCode":48,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"Department of Obstetrics and Gynecology, Semmelweis University","1088",{"type":50,"coordinates":62},[52,53],{"lat":53,"lon":52},[65],{"name":66,"role":35,"phone":36,"phoneExt":18,"email":67},"Kinga Kovács, MD","kovacs.kinga1@semmelwies.hu",{"type":31,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Dr. Gasparics Ákos","Chief Investigator, Assistant Lecturer","100546908","phase-4-the-effect-of-an-additional-pre-extubational-loading-dose-of-caffeine-citrate-100546908",false,"NCT06401083","The Effect of an Additional Pre-extubational Loading Dose of Caffeine-citrate","NEOKOFF22","Inclusion Criteria:\n\n* Premature infant born before 32nd week of gestation is completed;\n* Had been mechanically ventilated for at least 48 hours;\n* Before the first planned extubation.\n\nExclusion Criteria:\n\n* Lack of informed consent, refusal to participate in the study;\n* Major congenital anomaly;\n* Had not received surfactant treatment;\n* Hydrops foetalis;\n* Persistent tachycardia before extubation, fetal\u002Fneonatal arrhythmia;\n* Asphyxia.","ALL",{"count":80,"type":81},226,"ESTIMATED","INTERVENTIONAL",[84],"PHASE4","The goal of this clinical trial is to answer whether the use of a single loading dose (20 mg\u002Fkg) of caffeine citrate one hour before extubation has an impact on the success rate of extubation among preterm neonates. In addition, the investigators would like to assess the frequency of apneas and side effects of the intervention, as well as the development of NEC, BPD, IVH, PVL, and long-term neurodevelopmental outcomes in the investigated populations.\n\nAccording to institutional protocol, preterm infants born before the 32nd week of gestation receive a standard dose of caffeine citrate therapy. This covers a maintenance dose of 5-10 mg\u002Fkg of caffeine citrate administered intravenously once or twice daily after a loading dose of 20 mg\u002Fkg on the first day of life. In this trial, preterm infants born before the 32nd gestational week and who had been mechanically ventilated for at least 48 hours before planned extubation are planned to be randomly allocated into intervention and control groups. The intervention group will receive an additional loading dose of caffeine citrate 60 minutes before extubation. The control group will receive standard dosing regimens.",[87,88,89],"Apnea of Prematurity","Premature Birth","Respiratory Failure",[91,92,93,94,95],"prematurity","caffeine","methylxanthine","apnea of prematurity","extubation failure","2024-05-01",{"date":98,"type":99},"2024-05-06","ACTUAL",{"date":101,"type":99},"2023-12-21",{"date":103,"type":81},"2028-12",{"name":5,"class":6},2]