[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613090":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":34,"centralContacts":39,"locations":45,"responsibleParty":60,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":11,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":11,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":48,"whyStopped":11,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of Wisconsin, Madison","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Caffeine","EXPERIMENTAL",null,[13],"Drug: Caffeine citrate",{"label":15,"type":16,"description":11,"interventionNames":17},"Arm 2: Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",{"label":20,"type":21,"description":11,"interventionNames":11},"Arm 3: Control","NO_INTERVENTION",[23,28],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"DRUG","Caffeine citrate","intravenous (IV) caffeine citrate (20 milligrams per kilogram) followed by 8 milligrams per kilogram daily maintenance",[9],{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","same volume of 0.9 percent Sodium Chloride United States Pharmacopeia (USP)",[15],[33],"saline",[35],{"name":36,"affiliation":37,"role":38},"Matthew W Harer, MD","UW School of Medicine and Public Health","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":11,"email":44},"Elena Alfaro, CCRP","CONTACT","(608) 890-0584","elalfaro@wisc.edu",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":11},"UW Hospital and Clinics","RECRUITING","Madison","Wisconsin","53792","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-89.40123,43.07305,{"lat":58,"lon":57},{"type":61,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[63],{"name":64,"class":65},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100613090","phase-2-improving-preterm-kidney-outcomes-with-caffeine-100613090",false,"NCT07262060","Improving Preterm Kidney Outcomes With Caffeine","Optimizing Caffeine Therapy for Hypoxia in Preterm Neonates: A Randomized Trial Assessing Efficacy, Acute Kidney and Brain Injury, Safety, and Pharmacokinetics","Inclusion Criteria:\n\n* Gestational age at birth between 23 0\u002F7 and 29 6\u002F7 weeks.\n* Able to have near-infrared spectroscopy (NIRS) monitoring of cerebral and kidney oxygenation.\n* Able to receive IV medications.\n* Indwelling umbilical arterial catheter (UAC), umbilical venous catheter (UVC), peripheral arterial line (PAL), or peripherally inserted central catheter (PICC) already in place that can draw blood.\n* Receiving caffeine at the time of enrollment\n* Have a birth parent who is at least 18 years old and have a parent or guardian who is able to provide parental permission in English or Spanish\n\nExclusion Criteria:\n\n* Known or suspected major congenital anomaly of the brain, heart, lungs or kidney (excluding UTD A1 pyelectasis).\n* Known or suspected chromosomal or genetic anomaly.\n* Not suitable for study participation due to other reasons at the discretion of the investigators.","ALL","12 Hours","96 Hours",{"count":77,"type":78},114,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","This study is being done to see if additional caffeine citrate (20 milligrams per kilogram IV bolus) helps babies with low kidney oxygenation already being treated with caffeine citrate (20 milligrams per kilogram IV bolus on day of life (DOL) 1 followed by 8 milligrams per kilogram daily maintenance). The investigators hypothesize that additional caffeine will improve kidney oxygen levels, while not causing any brain injury, and may reduce rates of acute kidney injury compared to placebo. This study will take place in preterm babies born less than 30 weeks gestational age, with the intervention occurring between greater than 48 hours of age until DOL 14 and outcomes tracked until neonatal intensive care unit (NICU) discharge.",[84,85],"Kidney Injury","Pre-Term",[87,88],"caffeine","acute kidney injury","2026-06-02",{"date":91,"type":92},"2026-06-04","ACTUAL",{"date":94,"type":92},"2026-05-28",{"date":96,"type":78},"2030-09",{"name":5,"class":6},1]