[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551541":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":51,"centralContacts":59,"locations":29,"responsibleParty":68,"collaborators":70,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":29,"maxAge":29,"enrollmentInfo":100,"targetDuration":29,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":114,"whyStopped":29,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":29},{"fullName":5,"class":6},"University of Melbourne","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Pregnancy Domain 01 - PROMOAT: Preterm Rupture Of Membranes Optimal Antibiotics Trial","EXPERIMENTAL","ClinicalTrial.gov Trial Registration: NCT06906757.\n\nPopulation: Pregnant women and people with PPROM \\\u003C37 weeks' gestation and active neonatal management anticipated.\n\nInterventions: Randomised to receive routinely used broad-spectrum antibiotic prophylaxis",[13,14,15],"Drug: Erythromycin","Drug: Amoxicillin and Erythromycin","Drug: Azithromycin",{"label":17,"type":10,"description":18,"interventionNames":19},"Neonatal Domain 01 - BabyCCINO: Caffeine Citrate to Improve Neonatal Outcomes","ClinicalTrial.gov Trial Registration: NCT06972849.\n\nPopulation: Very preterm infants born \\\u003C32 weeks' gestation, up to 10 days old, with any clinical indication to commence caffeine treatment (any of: prevention of apnoea, treatment of apnoea, or with the aim of improving longer-term outcomes.\n\nInterventions: Randomised to receive high, medium and low-dose caffeine citrate.",[20,21,22],"Drug: Caffeine citrate 20 mg\u002Fkg load and 10 mg\u002Fkg daily maintenance.","Drug: Caffeine citrate 30 mg\u002Fkg load and 15 mg\u002Fkg daily maintenance.","Drug: Caffeine citrate 40 mg\u002Fkg load and 20 mg\u002Fkg daily maintenance",[24,30,36,39,43,47],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Erythromycin","Antibiotic. Standard of care. Antibiotics will be administered for 7 days or until delivery (whichever is sooner).",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Amoxicillin and Erythromycin","Antibiotic. Antibiotics will be administered for 7 days or until delivery (whichever is sooner).",[9],[35],"Amoxycillin",{"type":25,"name":37,"description":32,"armGroupLabels":38,"otherNames":29},"Azithromycin",[9],{"type":25,"name":40,"description":41,"armGroupLabels":42,"otherNames":29},"Caffeine citrate 20 mg\u002Fkg load and 10 mg\u002Fkg daily maintenance.","Lower dose caffeine: 20mg\u002Fkg load and 10mg\u002Fkg\u002Fday maintenance. Standard of care. Caffeine will be administered until at least 34+0 weeks' post-menstrual age, with the aim to cease caffeine by 36+0 weeks' post-menstrual age. Caffeine use beyond 36+0 weeks' post-menstrual age will be open-label.",[17],{"type":25,"name":44,"description":45,"armGroupLabels":46,"otherNames":29},"Caffeine citrate 30 mg\u002Fkg load and 15 mg\u002Fkg daily maintenance.","Medium dose caffeine: 30mg\u002Fkg load and 15 mg\u002Fkg\u002Fday maintenance. Caffeine will be administered until at least 34+0 weeks' post-menstrual age, with the aim to cease caffeine by 36+0 weeks' post-menstrual age. Caffeine use beyond 36+0 weeks' post-menstrual age will be open-label.",[17],{"type":25,"name":48,"description":49,"armGroupLabels":50,"otherNames":29},"Caffeine citrate 40 mg\u002Fkg load and 20 mg\u002Fkg daily maintenance","Higher dose caffeine: 40mg\u002Fkg load and 20mg\u002Fkg\u002Fday maintenance. Caffeine will be administered until at least 34+0 weeks' post-menstrual age, with the aim to cease caffeine by 36+0 weeks' post-menstrual age. Caffeine use beyond 36+0 weeks' post-menstrual age will be open-label.",[17],[52,56],{"name":53,"affiliation":54,"role":55},"Clare Whitehead, MBChB, PhD","University of Melbourne, Royal Women's Hospital, Melbourne.","PRINCIPAL_INVESTIGATOR",{"name":57,"affiliation":58,"role":55},"Brett Manley, MBBS, PhD","University of Melbourne, Royal Women's Hospital, Melbourne",[60,64],{"name":53,"role":61,"phone":62,"phoneExt":29,"email":63},"CONTACT","+61","clarew@unimelb.edu.au",{"name":65,"role":61,"phone":66,"phoneExt":29,"email":67},"Kelly Fredell","+61432975273","kelly.fredell@unimelb.edu.au",{"type":69,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[71,73,75,77,79,81,83,85,87,89],{"name":72,"class":6},"University of Auckland, New Zealand",{"name":74,"class":6},"Monash University",{"name":76,"class":6},"The University of Western Australia",{"name":78,"class":6},"La Trobe University",{"name":80,"class":6},"The University of New South Wales",{"name":82,"class":6},"University of Tasmania",{"name":84,"class":6},"Menzies School of Health Research",{"name":86,"class":6},"University of Adelaide",{"name":88,"class":6},"University of Sydney",{"name":90,"class":6},"Mater Medical Research Institute","100551541","platform-for-adaptive-trials-in-perinatal-units---core-protocol-100551541",false,"NCT06461429","PLatform for Adaptive Trials In Perinatal UnitS - [Core Protocol]","Platform for Adaptive Trials in Perinatal Units (Core Protocol)","PLATIPUS","Potential participants with core platform eligibility AND who meet all domain-specific inclusion criteria and none of the domain-specific exclusion criteria for at least one PLATIPUS domain, will be eligible to 'enrol' in the PLATIPUS trial and randomised to all eligible domains, for which consent has been provided.\n\nCORE PLATFORM ELIGIBILITY - PREGNANCY DOMAINS\n\nInclusion Criteria: Pregnant women and people must fulfil the following inclusion criteria to be eligible to participate in PLATIPUS:\n\n1. Pregnant and at risk of preterm birth\n2. Receiving care at a participating site at the time of eligibility assessment.\n3. Meets the eligibility criteria for at least one domain.\n\nExclusion Criteria: Pregnant women and people who meet the following criteria will be excluded from participation in this trial:\n\n1. Circumstances where death (pregnant woman or person\u002Ffetal) is deemed to be imminent and inevitable. The treating team may however decide that providing an opportunity for the pregnant woman or person to participate would be in their and\u002For their fetus\u002Finfant's interest. OR\n2. Inability to consent, unless a waiver of consent has been deemed appropriate at domain-level.\n\nCORE PLATFORM ELIGIBILITY - NEONATAL DOMAINS\n\nInclusion Criteria: Preterm infants must fulfil the following criteria to be eligible to participate in PLATIPUS, infants must be:\n\n1. Born preterm (\\\u003C37 weeks' gestational age)\n2. Receiving care at a participating site at the time of eligibility assessment.\n3. Meet the eligibility criteria for at least one domain.\n\nExclusion Criteria: Preterm infants who meet the following criteria will be excluded from participation in this trial:\n\n1. Circumstances where death (neonatal) is deemed to be imminent and inevitable. The treating team may however decide that providing an opportunity for the infant to participate is in the infant's interest. OR\n2. Parental\u002Fguardian inability to consent, unless a waiver of consent has been deemed appropriate at domain-level.\n\nDOMAIN-SPECIFIC ELIGIBILITY CRITERIA\n\nPotential participants who meet core platform eligibility criteria will be assessed for eligibility to participate in trial domains available at their hospital. Domain-specific eligibility criteria are outlined in the related Domain-Specific Appendices.","ALL",{"count":101,"type":102},100000,"ESTIMATED","INTERVENTIONAL",[105],"NA","PLATIPUS is an adaptive platform trial aimed at improving the health of infants born preterm (before 37 weeks' gestation). PLATIPUS will compare how different treatments and care provided to pregnant women and people at risk of preterm birth and infants born preterm affect infant health.\n\nThe main questions PLATIPUS aims to answer are:\n\n1. What effect\u002Fs do different treatments\u002Fcare provided to pregnant women and people at risk of preterm birth have on the health of their infants? (Pregnancy domains)\n2. What effect\u002Fs do different treatments\u002Fcare given to infants born preterm have on their health ? (Neonatal domains).\n\nThis registration record relates to the PLATIPUS Core (or 'master') protocol which provides guidance for the overall running of the trial. Additional appendices will outline the aims, questions, treatments, and activities for each separate research question (domain). Each Domain-Specific Appendix will be registered separately on ClinicalTrials.gov and will link to this record.",[108],"Preterm Birth",[110,111,112,113],"Preterm infant","Pregnancy","Neonatal complications","Preterm labor","NOT_YET_RECRUITING","2025-06-10",{"date":117,"type":118},"2025-06-13","ACTUAL",{"date":120,"type":102},"2025-11-01",{"date":122,"type":102},"2050-12-31",{"name":5,"class":6}]