[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628056":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":53,"collaborators":32,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":32,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":84,"whyStopped":32,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Queen's University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Caffeine Citrate Group","EXPERIMENTAL","Infants in this arm will receive a loading dose of caffeine base (10 mg\u002Fkg), followed by a daily maintenance dose (5 mg\u002Fkg). The study drug will be administered intravenously or enterally (once full oral feeds are established) until 24 hours after the successful weaning of respiratory support",[13],"Drug: Caffeine",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group","PLACEBO_COMPARATOR","Infants in this arm will receive an equivalent volume of 0.9% normal saline (placebo) instead of caffeine. The loading dose and daily maintenance doses will follow the same schedule and administration routes (intravenous or enteral) as the experimental arm. The placebo will be administered until 24 hours after the successful weaning of respiratory support.",[19],"Other: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Caffeine","Infants randomized to this arm will receive caffeine citrate administered as a 10 mg\u002Fkg loading dose (caffeine base equivalent), followed by a 5 mg\u002Fkg daily maintenance dose (caffeine base equivalent).",[9],[27],"caffeine Base",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","Infants randomized to this arm will receive 0.9% normal saline administered in a volume equivalent to the caffeine citrate arm. The placebo will be administered as a loading dose followed by a daily maintenance dose matching the volume and timing of the experimental protocol",[15],null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Eyad Bitar, MD","CONTACT","+1 (613) 548-6053","eyad.bitar@queensu.ca",[40],{"facility":41,"status":32,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":32},"Kingston Health Science Center","Kingston","Ontario","K7L 2V7","Canada","CA",{"type":48,"coordinates":49},"Point",[50,51],-76.48098,44.22976,{"lat":51,"lon":50},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Eyad Bitar","Assistant Professor, Department of Pediatrics","100628056","phase-2-caffeine-for-infants-born-at-28-to-34-weeks-receiving-respiratory-support-100628056",false,"NCT07456670","Caffeine for Infants Born at 28 to 34 Weeks Receiving Respiratory Support","Caffeine Therapy in Preterm Infants Born at 28-34 Weeks: A Pilot Placebo-Controlled Randomized Controlled Trial","CARES-Pilot","Inclusion Criteria:\n\n* Infant born at a gestational age between 28+0 and 34+6 weeks.\n* Admitted to the Neonatal Intensive Care Unit (NICU) within the first 72 hours of life.\n* Requiring either invasive respiratory support (mechanical ventilation) or non-invasive respiratory support (e.g., CPAP, High Flow Nasal Cannula) within the first 72 hours of life.\n* Informed consent obtained from parent(s) or legal guardian(s).\n\nExclusion Criteria:\n\n* Presence of dysmorphic features or major congenital malformations that adversely affect life expectancy.\n* Known or strongly suspected cyanotic heart disease.\n* Infants born at \\\u003C28 weeks' gestational age (due to high risk of apnea requiring routine caffeine).\n* Late preterm infants born at ≥35+0 weeks' gestational age (due to short NICU stay not allowing for a safe caffeine-free period before discharge).","ALL","0 Days","28 Days",{"count":69,"type":70},62,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","The goal of this pilot clinical trial is to test if it is possible to conduct a larger study on the use of caffeine in preterm infants who need help with their breathing. It will also look at whether caffeine helps these infants get healthy enough to leave the hospital sooner.\n\nThe main questions the researchers aim to answer are:\n\nCan the investigators successfully recruit and keep enough participants in the study? Do the medical teams follow the study drug instructions correctly? Does caffeine reduce the total time infants spend in the Neonatal Intensive Care Unit (NICU)? Researchers will compare caffeine to a placebo (a look-alike substance with no active medicine) to see if caffeine is a helpful treatment for babies born between 28 and 34 weeks of gestation who are using a breathing machine or oxygen.\n\nParticipants will:\n\nBe randomly assigned to receive either caffeine or a placebo through an IV or a feeding tube.\n\nReceive the study treatment once a day as long as they require respiratory support (and for 24 hours after they stop).\n\nBe monitored by the research team for clinical outcomes like feeding progress, breathing stability, and growth until they are discharged from the hospital.",[76,23,77],"Preterm Birth","Neonatal Outcomes",[23,79,80,81,82,83],"Neonatal Intensive Care Unit","Prematurity","RCT","NICU","Pilot Study","NOT_YET_RECRUITING","2026-03-06",{"date":87,"type":88},"2026-03-10","ACTUAL",{"date":90,"type":70},"2026-04-01",{"date":92,"type":70},"2028-03-31",{"name":5,"class":6},1]