[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06049680":3,"trial-entities:NCT06049680":196,"trial-summary:NCT06049680":201},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":54,"sex":100,"minimum_age":101,"maximum_age":102,"healthy_volunteers":103,"eligibility_criteria":104,"std_ages":108,"locations":110,"central_contacts":179,"overall_officials":189,"references":194,"see_also_links":195},"NCT06049680","SMOF-044-CP4 (PMR 4240-1)","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","RECRUITING","2026-09","2026-07","2026-07-17","2024-10-28","Fresenius Kabi","INDUSTRY",true,"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.",null,[19,20,21,22],"Malnutrition, Child","Malnutrition","Essential Fatty Acid Deficiency (EFAD)","Parenteral Nutrition Associated Cholestasis",[],"INTERVENTIONAL","OTHER",[27],"PHASE4",{"count":29,"type":30},100,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"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.",[37],"Single arm SMOFlipid® (lipid injectable emulsion)",[39,43,46,49,51],{"measure":40,"description":41,"timeFrame":42},"Incidence of PNAC","defined as direct bilirubin level \\> 2 mg\u002FdL, confirmed by a second sample collected 7 days after the first sample","Start of Treatment until After End of Last Study PN Duration of Treatment: Study treatment will last for a minimum of 8 weeks (56 consecutive days) and as long as PN is indicated, up to 1 year (365 consecutive days).",{"measure":44,"description":45,"timeFrame":42},"Time to direct bilirubin > 2mg\u002FdL","(confirmed by a second sample collected 7 days after the first)",{"measure":47,"description":48,"timeFrame":42},"Incidence of EFAD","Triene\u002Ftetraene ratio in total plasma to assess EFAD (Holman 1960), Severity of EFAD will be graded based on triene\u002Ftetraene ratio, as suspected ≥ 0.05, moderate ≥ 0.20 and severe ≥ 0.40 (Cober et al 2012)",{"measure":50,"timeFrame":42},"Incidence of clinical EFAD",{"measure":52,"description":53,"timeFrame":42},"Fatty acids","analyzed in total plasma, including linoleic acid, α-linolenic acid, arachidonic acid, docosahexaenoic acid, eicosapentaenoic acid and Mead acid",[55,57,59,61,63,65,67,69,71,73,75,77,79,81,83,85,88,90,92,94,97],{"measure":56,"timeFrame":42},"Laboratory values: triglycerides",{"measure":58,"timeFrame":42},"Laboratory values: direct bilirubin",{"measure":60,"timeFrame":42},"Laboratory values: total bilirubin",{"measure":62,"timeFrame":42},"Laboratory values: alanine aminotransferase (ALT)",{"measure":64,"timeFrame":42},"Laboratory values: aspartate aminotransferase (AST)",{"measure":66,"timeFrame":42},"Laboratory values: gamma-glutamyl transferase (GGT)",{"measure":68,"timeFrame":42},"Laboratory values: alkaline phosphatase (ALP)",{"measure":70,"timeFrame":42},"Laboratory values: creatinine",{"measure":72,"timeFrame":42},"Laboratory values: urea nitrogen",{"measure":74,"timeFrame":42},"Laboratory values: electrolytes",{"measure":76,"timeFrame":42},"Laboratory values: glucose",{"measure":78,"timeFrame":42},"Laboratory values: total protein",{"measure":80,"timeFrame":42},"Laboratory values hematology: white blood cell count (WBC), red blood cell count (RBC), and platelet count",{"measure":82,"timeFrame":42},"Laboratory values hematology: Hemoglobin",{"measure":84,"timeFrame":42},"Laboratory values hematology Hematocrit",{"measure":86,"timeFrame":87},"Laboratory values hematology: International normalized ratio","At baseline before start of treatment to assess eligibility",{"measure":89,"timeFrame":42},"Vital signs: Blood pressure",{"measure":91,"timeFrame":42},"Vital signs: Heart rate",{"measure":93,"timeFrame":42},"Vital signs: Body temperature",{"measure":95,"timeFrame":96},"Incidence of adverse events","Start of Treatment until After End of Last Study PN (+6 months for pediatric patients). Study treatment will last for a minimum of 8 weeks (56 consecutive days) and as long as PN is indicated, up to 1 year (365 consecutive days).",{"measure":98,"description":99,"timeFrame":42},"BMI","BMI is the weight in kilograms divided by height in meters squared. Alternatively, BMI can be calculated by dividing the weight in kilograms by the height in centimeters squared, and then multiplying the result by 10,000.","ALL","1 Month","17 Years",false,{"inclusion":105,"exclusion":106,"raw_text":107},[],[],"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.",[109],"CHILD",[111,126,140,153,166],{"facility":112,"status":8,"city":113,"state":114,"zip":115,"country":116,"contacts":117,"geoPoint":123},"Emory University Hospital","Atlanta","Georgia","30322","United States",[118],{"name":119,"role":120,"phone":121,"email":122},"Thomas R. Ziegler, M.D.","CONTACT","404-727-7351","tzieg01@emory.edu",{"lat":124,"lon":125},33.749,-84.38798,{"facility":127,"status":128,"city":129,"state":130,"zip":131,"country":116,"contacts":132,"geoPoint":137},"The University of Chicago","NOT_YET_RECRUITING","Chicago","Illinois","60638",[133],{"name":134,"role":120,"phone":135,"email":136},"Edwin R. McDonald, M.D.","(773) 702-3075","Edwin.McDonald@uchicagomedicine.org",{"lat":138,"lon":139},41.85003,-87.65005,{"facility":141,"status":8,"city":142,"state":143,"zip":144,"country":116,"contacts":145,"geoPoint":150},"Riley Hospital for Children","Indianapolis","Indiana","46202",[146],{"name":147,"role":120,"phone":148,"email":149},"Charles Vanderpool, MD","317-944-2078","chavande@iupui.edu",{"lat":151,"lon":152},39.76838,-86.15804,{"facility":154,"status":8,"city":155,"state":156,"zip":157,"country":116,"contacts":158,"geoPoint":163},"Nationwide Children's Hospital","Columbus","Ohio","43205",[159],{"name":160,"role":120,"phone":161,"email":162},"Ethan Mezoff, Dr.","614 722 2286","ethan.mezoff@nationwidechildrens.org",{"lat":164,"lon":165},39.96118,-82.99879,{"facility":167,"status":8,"city":168,"state":169,"zip":170,"country":116,"contacts":171,"geoPoint":176},"Children's Hospital of Pittsburgh of UPMC","Pittsburgh","Pennsylvania","15224",[172],{"name":173,"role":120,"phone":174,"email":175},"Jeffrey Alan Rudolph, MD","7248144905","jeffrey.rudolph@chp.edu",{"lat":177,"lon":178},40.44062,-79.99589,[180,185],{"name":181,"role":120,"phone":182,"phoneExt":183,"email":184},"Martin Stumpf, PhD","+49 6172 686","8655","martin.stumpf@fresenius-kabi.com",{"name":186,"role":120,"phone":182,"phoneExt":187,"email":188},"Jean-Marc Lohse, PhD","4911","Jean-Marc.Lohse@fresenius-kabi.com",[190],{"name":191,"affiliation":192,"role":193},"Jeffrey Rudolph, MD","University of Pittsburgh","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":197,"biomarkers":200},[198,20,199],"Essential fatty acid deficiency","Parenteral Nutrition - Associated Cholestasis",[],{"nct_id":4,"found":15,"summary":202,"prompt_version":212},{"design":203,"status":204,"heading":205,"summary":206,"follow_up":207,"word_count":208,"commitments":209,"compensation":210,"drugs_mentioned":211},"This is an interventional study, meaning participants will receive a specific treatment (SMOFlipid). It aims to enroll 100 participants, including children and adults.","completed","Safety Study of SMOFlipid for Malnutrition in Children and Adults","This study is looking at the safety of SMOFlipid, a special liquid nutrition given through a vein (intravenous infusion), for children and adults who need long-term feeding this way. SMOFlipid is a mix of different oils. Researchers want to see if using SMOFlipid can help prevent two problems: Essential Fatty Acid Deficiency (EFAD), which is when your body doesn't get enough important fats, and Parenteral Nutrition Associated Cholestasis (PNAC), a liver problem. The study includes patients aged 1 month and older who are expected to receive this type of nutrition for at least 8 weeks. The study aims to enroll 100 participants, but its current recruitment status is unclear.","Participants will be monitored from the start of treatment until after the end of their last study nutrition treatment, which can last up to one year.",109,"Participants will receive SMOFlipid as part of their nutritional support for a minimum of 8 weeks and up to one year, as long as they need this type of nutrition.","Not stated in the trial record.",[],"v2"]