[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519909":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":37,"responsibleParty":118,"collaborators":20,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":20,"eligibilityCriteria":126,"healthyVolunteers":122,"sex":127,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":20,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":20,"overallStatus":40,"whyStopped":20,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Fresenius Kabi","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single arm SMOFlipid® (lipid injectable emulsion)","OTHER","Investigational drug: SMOFlipid® (lipid injectable emulsion).",[13],"Drug: SMOFlipid® (lipid injectable emulsion)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","SMOFlipid® (lipid injectable emulsion)","SMOFlipid is a sterile, nonpyrogenic, white, homogenous lipid emulsion for intravenous infusion. The lipid content of SMOFlipid is 0.20 g\u002FmL, and comprises a mixture of soybean oil, MCT, olive oil, and fish oil. SMOFlipid belongs to the pharmacotherapeutic group: \"Solutions for parenteral nutrition, fat emulsions\" (ATC-code: B05BA02). SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Jeffrey Rudolph, MD","University of Pittsburgh","PRINCIPAL_INVESTIGATOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Martin Stumpf, PhD","CONTACT","+49 6172 686","8655","martin.stumpf@fresenius-kabi.com",{"name":34,"role":29,"phone":30,"phoneExt":35,"email":36},"Jean-Marc Lohse, PhD","4911","Jean-Marc.Lohse@fresenius-kabi.com",[38,57,73,88,103],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Emory University Hospital","RECRUITING","Atlanta","Georgia","30322","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-84.38798,33.749,{"lat":50,"lon":49},[53],{"name":54,"role":29,"phone":55,"phoneExt":20,"email":56},"Thomas R. Ziegler, M.D.","404-727-7351","tzieg01@emory.edu",{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":44,"countryCode":45,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"The University of Chicago","NOT_YET_RECRUITING","Chicago","Illinois","60638",{"type":47,"coordinates":64},[65,66],-87.65005,41.85003,{"lat":66,"lon":65},[69],{"name":70,"role":29,"phone":71,"phoneExt":20,"email":72},"Edwin R. McDonald, M.D.","(773) 702-3075","Edwin.McDonald@uchicagomedicine.org",{"facility":74,"status":40,"city":75,"state":76,"zip":77,"country":44,"countryCode":45,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Riley Hospital for Children","Indianapolis","Indiana","46202",{"type":47,"coordinates":79},[80,81],-86.15804,39.76838,{"lat":81,"lon":80},[84],{"name":85,"role":29,"phone":86,"phoneExt":20,"email":87},"Charles Vanderpool, MD","317-944-2078","chavande@iupui.edu",{"facility":89,"status":59,"city":90,"state":91,"zip":92,"country":44,"countryCode":45,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Nationwide Children's Hospital","Columbus","Ohio","43205",{"type":47,"coordinates":94},[95,96],-82.99879,39.96118,{"lat":96,"lon":95},[99],{"name":100,"role":29,"phone":101,"phoneExt":20,"email":102},"Ethan Mezoff, Dr.","614 722 2286","ethan.mezoff@nationwidechildrens.org",{"facility":104,"status":40,"city":105,"state":106,"zip":107,"country":44,"countryCode":45,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Children's Hospital of Pittsburgh of UPMC","Pittsburgh","Pennsylvania","15224",{"type":47,"coordinates":109},[110,111],-79.99589,40.44062,{"lat":111,"lon":110},[114],{"name":115,"role":29,"phone":116,"phoneExt":20,"email":117},"Jeffrey Alan Rudolph, MD","7248144905","jeffrey.rudolph@chp.edu",{"type":119,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100519909","phase-4-safety-study-of-smoflipid-to-evaluate-the-risk-of-developing-efad-andor-pnac-in-pediatric-and-adult-patients-100519909",false,"NCT06049680","Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and\u002For PNAC in Pediatric and Adult Patients","A Single-arm Open-label Safety Study of SMOFlipid to Evaluate the Risk of Developing Essential Fatty Acid Deficiency (EFAD) and\u002For Parenteral Nutrition-associated Cholestasis (PNAC) in Pediatric Patients 1 Month to 17 Years of Age and in Adult Patients, Who Are Anticipated to Need 8 Weeks or Longer of Parenteral Nutrition Treatment","Age Limits: and Adults\n\nInclusion Criteria:\n\n1. Male or female patients, at least 1 month of age.\n2. Patients who require PN for at least 5 days\u002Fweek.\n3. Patients who receive 80% or more of their total energy requirements as PN at enrollment and who are expected to receive 80% or more of their total energy requirements as PN for at least 56 days.\n4. Written informed consent. In case of pediatric patients, informed consent must be obtained from parent(s) or legal representatives. If possible, the assent of the pediatric patient must also be obtained (according to local law).\n\nExclusion Criteria:\n\n1. Use of any other lipid injectable emulsion than SMOFlipid within 6 months prior to study participation\n2. Known hypersensitivity to fish, egg, soybean, or peanut proteins, or to any of the active ingredients or excipients of SMOFlipid.\n3. Hyperlipidemia or disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentration \\>250 mg\u002FdL in infants or \\>400 mg\u002FdL in older pediatric and adult patients).\n4. Inborn errors of amino acid metabolism.\n5. Cardiopulmonary instability (including pulmonary edema, cardiac insufficiency, myocardial infarction, acidosis and hemodynamic instability requiring significant vasopressor support).\n6. Hemophagocytic syndrome.\n7. Liver enzymes (either AST, or ALT, or GGT) exceeding 2 x upper limit of normal range\n8. Direct bilirubin exceeding 2 x upper limit of normal range\n9. INR exceeding 2 x upper limit of normal range and patient not receiving oral anticoagulants.\n10. Any known hepatic condition outside of IFALD that will increase direct bilirubin ≥2.0 mg\u002FdL.\n11. Clinically significant abnormal levels of any serum electrolyte (sodium, potassium, magnesium, calcium, chloride, phosphate).\n12. Active bloodstream infection demonstrated by positive blood culture at screening.\n13. Severe renal failure (eGFR \\\u003C15 ml\u002Fmin per 1.73 m2) including patients on renal replacement therapy.\n14. Abnormal blood pH, oxygen saturation, or carbon dioxide.\n15. Pregnancy or lactation.\n16. Participation in another interventional clinical study.\n17. Unlikely to survive longer than 56 days.","ALL","1 Month","17 Years",{"count":131,"type":132},100,"ESTIMATED","INTERVENTIONAL",[135],"PHASE4","Evaluate the risk of developing EFAD and\u002For PNAC in adult and pediatric patients 1 month of age and older, who are anticipated to need 8 weeks or longer of parenteral nutrition treatment with SMOFlipid.",[138,139,140,141],"Malnutrition, Child","Malnutrition","Essential Fatty Acid Deficiency (EFAD)","Parenteral Nutrition Associated Cholestasis","2025-12-03",{"date":144,"type":145},"2025-12-04","ACTUAL",{"date":147,"type":145},"2024-10-28",{"date":149,"type":132},"2026-09",{"name":5,"class":6},5]