[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590855":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":30,"centralContacts":34,"locations":39,"responsibleParty":44,"collaborators":39,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":39,"maxAge":55,"enrollmentInfo":56,"targetDuration":39,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":68,"whyStopped":39,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":39},{"fullName":5,"class":6},"University of Melbourne","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Caffeine citrate 40mg","ACTIVE_COMPARATOR","Dose and frequency 40mg\u002Fkg load and 20mg\u002Fkg maintenance daily, as long as clinically indicated.\n\nAdministration Loading dose: 2mL\u002Fkg loading dose of study drug, either IV or enterally, administered at \\\u003C72 hours of life, followed by Maintenance dose: 1mL\u002Fkg maintenance dose given daily, either IV or enterally, commenced 24 hours after loading dose.",[13],"Drug: Caffeine citrate",{"label":15,"type":10,"description":16,"interventionNames":17},"Caffeine citrate 30mg","Dose and frequency 30 mg\u002Fkg load and 15mg\u002Fkg maintenance daily, as long as clinically indicated.\n\nAdministration Loading dose: 2mL\u002Fkg loading dose of study drug, either IV or enterally, administered at \\\u003C72 hours of life, followed by Maintenance dose: 1mL\u002Fkg maintenance dose given daily, either IV or enterally, commenced 24 hours after loading dose.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Caffeine citrate 20mg","Dose and frequency 20mg\u002Fkg load and 10mg\u002Fkg maintenance daily, as long as clinically indicated.\n\nAdministration Loading dose: 2mL\u002Fkg loading dose of study drug, either IV or enterally, administered at \\\u003C72 hours of life, followed by Maintenance dose: 1mL\u002Fkg maintenance dose given daily, either IV or enterally, commenced 24 hours after loading dose.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Caffeine citrate","Clinically indicated for apnea of prematurity.",[19,15,9],[29],"Cafcit",[31],{"name":32,"affiliation":5,"role":33},"Brett Manley, MBChB PhD","PRINCIPAL_INVESTIGATOR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Brett Manley, MB BS, PhD","CONTACT","00610383452000",null,"Brett.Manley@unimelb.edu.au",{"name":42,"role":37,"phone":39,"phoneExt":39,"email":43},"Kelly Fredell","info@platipustrial.org",{"type":45,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100590855","caffeine-citrate-to-improve-neonatal-outcomes-100590855",false,"NCT06972849","Caffeine Citrate to Improve Neonatal Outcomes.","BabyCCINO: Caffeine Citrate to Improve Neonatal Outcomes. A Neonatal Domain Within PLATIPUS.","BabyCCINO","PLATFORM ELIGIBILITY\n\nParticipants must meet all core PLATIPUS platform inclusion criteria:\n\n* Born before 37 weeks gestation\n* Receiving pregnancy care at a participating site (hospital) at the time of eligibility assessment and\n* Meet eligibility criteria for one or more platform domains.\n\nParticipants will be excluded from participation if they meet any core PLATIPUS platform exclusion criteria:\n\n* (Parent) Inability to consent for their infant, unless a domain-level waiver of consent is deemed appropriate.\n* Perinatal death is deemed to be imminent and inevitable during the next 24 hours (at time of screening), including if neonatal intensive care is not being provided to the infant.\n\nInfants who meet ALL of the core platform inclusion criteria and none of the exclusion criteria will be considered for BabyCCINO-specific eligibility.\n\nBabyCCINO-SPECIFIC ELIGIBILITY\n\nPlatform-eligible participants must meet all BabyCCINO-specific inclusion criteria:\n\n1. Very preterm infants born \\\u003C32 weeks' gestation\n2. \\\u003C72 hours old\n3. Very preterm infants born at \\\u003C32 weeks' gestation, \\\u003C72 hours of age, with any clinical indication for commencing caffeine, as determined by the treating clinician, including:\n\n   * Prevention or treatment of apnoea\n   * Facilitating extubation from mechanical ventilation\n   * Prevention of BPD\n   * For longer-term benefit.\n\nParticipants will be excluded from participation if they meet any BabyCCINO-specific exclusion criteria:\n\n1. Prior treatment with caffeine, other methylxanthines, or doxapram\n2. Major congenital anomalies: major congenital cardiac disease (not including patent ductus arteriosus or isolated atrial\u002Fventricular septal defects), major gastrointestinal malformations, congenital diaphragmatic hernia, known genetic syndromes, known brain malformations\n3. Death considered to be imminent in the next 24 hours, or intensive care not going to be offered or continued\n4. Pre-existing tachyarrhythmia (e.g., antenatal or postnatal supraventricular tachycardia)\n5. Pre-existing seizures\n6. No parental\u002Fcaregiver consent or not satisfying the principles and criteria for waiver with consent to continue, as approved in the relevant jurisdiction\n\nPlatform-eligible participants who meet all BabyCCINO-specific inclusion criteria and none of the BabyCCINO-specific exclusion criteria will be eligible to participate in BabyCCINO.","ALL","32 Weeks",{"count":57,"type":58},3900,"ESTIMATED","INTERVENTIONAL",[61],"NA","The goal of this clinical trial to learn what dose\u002Fs of caffeine citrate works to treat preterm born babies who have episodes where they stop breathing. It will also learn about the safety of different doses of caffeine citrate for the variety of preterm-born babies that are prescribed this.\n\nThe main question it aims to answer is: Which dose is the optimal dose of caffeine citrate for very preterm babies to prevent short-term death and disease?\n\nResearchers will compare three different doses of caffeine citrate, which are already used in clinical practice to treat breathing stoppages in preterm babies, to see which dose works best. No placebo will be used.\n\nParticipants will be given a 'loading' dose of caffeine citrate \\\u003C72 hours of life, and a smaller 'maintenance' dose once a day, for as long as the baby needs this.\n\nThis trial will be undertaken as part of the PLATIPUS trial (NCT06461429).",[64],"Apnea of Prematurity",[66,64,67,25],"Preterm infant","Apnoea of Prematurity","NOT_YET_RECRUITING","2025-05-06",{"date":71,"type":72},"2025-05-15","ACTUAL",{"date":74,"type":58},"2025-10",{"date":76,"type":58},"2050-12",{"name":5,"class":6}]