[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555939":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":62,"collaborators":65,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":26,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":26,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral Caffeine Citrate 20mg\u002Fkg\u002Fday","EXPERIMENTAL","Caffeine Citrate 20 mg\u002Fkg\u002Fday given orally once a day for 28 days. (2mg\u002Fml)",[13],"Drug: Caffeine citrate 20mg\u002Fkg\u002Fday",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Sterile water 1ml\u002Fkg\u002Fday given orally once a day for 28 days.",[19],"Drug: Placebo-Sterile water 1ml\u002Fkg\u002Fday",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Caffeine citrate 20mg\u002Fkg\u002Fday","Caffeine citrate 20mg\u002Fkg\u002Fday given orally once daily for 28 days",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo-Sterile water 1ml\u002Fkg\u002Fday","Placebo-sterile water 1mg\u002Fkg\u002Fday given orally once daily for 28 days",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Albert Manasyan, MD","CONTACT","+260 976 448 994","Albert.Manasyan@cidrz.org",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Waldemar A Carlo, MD","2059344680","wacarlo@uabmc.edu",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"University Teaching Hospital","RECRUITING","Lusaka","Lusaka Province","10100","Zambia","ZM",{"type":51,"coordinates":52},"Point",[53,54],28.28713,-15.40669,{"lat":54,"lon":53},[57,58,59],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},{"name":60,"role":61,"phone":26,"phoneExt":26,"email":26},"Jyoti Lakhwani, MD","PRINCIPAL_INVESTIGATOR",{"type":61,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Albert Manasyan, MD, MPH","Associate Professor",[66,68],{"name":67,"class":6},"University Teaching Hospital, Lusaka, Zambia",{"name":69,"class":6},"Centre for Infectious Disease Research in Zambia","100555939","phase-4-caffeine-citrate-in-preterm-infants-at-risk-of-apnea-in-zambia-100555939",false,"NCT06518603","Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia","Randomized Controlled Trial of Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia","Inclusion Criteria:\n\nNewborns:\n\n1. 29 0\u002F7 to 33 6\u002F7 weeks GA (or with a birth weight 1.0 to 2.0 kg if pregnancy dating is unreliable) admitted to the UTH NICU,\n2. On methylxanthines with plans to discontinue on methylxanthine,\n3. Off oxygen therapy for \\>48 hours at the time of evaluation for eligibility,\n4. Receiving full daily feeds,\n5. Deemed stable and ready to go off caffeine as recommended by the Neonatologist\n6. 18+ years of age (parent)\n\nExclusion Criteria:\n\n1. Newborns with neuromuscular conditions affecting respiration,\n2. Major congenital malformations and genetic disorders,\n3. Unable to obtain parental or guardian consent","ALL","0 Days","12 Months",{"count":81,"type":82},340,"ESTIMATED","INTERVENTIONAL",[85],"PHASE4","The goal of this clinical trial is to learn if caffeine citrate prevents apneic events that result in sick visits in moderately preterm infants after discharge from the hospital. It will also learn if the use of caffeine leads to better developmental outcomes at 12 months of age.\n\nOur research questions are:\n\n1. Does continued treatment of moderately preterm newborns with caffeine citrate after hospital discharge prevent or decrease apneic events that result in sick visits?\n2. Will the continued use of caffeine citrate lead to improved developmental outcomes among infants at 12 months of age?\n\nResearchers will compare caffeine citrate to a placebo (a look-alike substance that contains no drug) to see if caffeine citrate prevents apneic spells which result in healthcare visits.\n\nParents of participants will:\n\n1. Administer caffeine citrate 20mg\u002Fkg\u002Fday or a placebo (equivalent volume of sterile water) orally every day for up to 28 days after hospital discharge\n2. Keep a diary of symptoms and any apneic events\n3. Check in with researchers via telephone call once a week\n4. Return to clinic for infant physical examination at 28 days\n5. Return to the clinic for infant physical examination at 2 months\n\n5\\. Return to clinic for infant neurodevelopmental examination with Ages and Stages Questionnaire at 12 months of age",[88,89,90],"Premature Infant Disease","Apnea of Prematurity","Development, Infant","2026-06-18",{"date":93,"type":94},"2026-06-23","ACTUAL",{"date":96,"type":94},"2026-06-17",{"date":98,"type":82},"2027-06-30",{"name":5,"class":6},1]