5 completed, 2 terminated, 2 unknown, 2 withdrawn. 12 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 12 | Completed 5, Terminated 2, Unknown 2, Withdrawn 2, Recruiting 1 |
Follow SMOFlipid: new trials by email Literature Review of SMOFlipid trials Research Report on SMOFlipid
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients SMOFlipid® (lipid injectable emulsion) - Malnutrition, Child, Malnutrition | Phase 4 | Recruiting | Fresenius Kabi | 100 | 2024-10-28 | 2026-10-22 |
| Effects of Fat Emulsions on PNALD and Oxidative Stress in Premature Infants SMOFlipid, Lipofundin - Preterm Infant | Phase 4 | Unknown | Shanghai Jiao Tong University School of Medicine | 66 | 2020-02-01 | 2020-02-20 |
| Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age Smoflipid, Intralipid, 20% - Malnutrition, Child | Phase 4 | Terminated | Fresenius Kabi | 1 | 2019-12-18 | 2022-12-12 |
| SMOFLipid in Patients Who Are Intralipid Intolerant SMOFLipid, Standard therapy - Home Parenteral Nutrition, Short Bowel Syndrome | Phase 4 | Withdrawn | Mayo Clinic | 2017-02-01 | 2018-03-22 | |
| Rate of Bronchopulmonary Dysplasia in Preterms Neonates: a Trial Comparing SMOFlipid and Medialipide SMOFlipid®, Medialipide® - Preterm Neonates | Phase 4 | Withdrawn | Hospices Civils de Lyon | 2017-01-01 | 2019-07-24 | |
| The Effects of Two Different Intravenous Lipid Emulsions on the Outcomes of Preterm Infants With Sepsis Smoflipid ® - Sepsis Newborn | Phase 4 | Completed | Mansoura University Children Hospital | 40 | 2016-02-01 | 2018-03-23 |
| Lipids and Neurological Complications in Liver Transplantation SMOF lipid (SMOFLIPID) pre treatment - Neurological Complications | Phase 4 | Unknown | Mansoura University | 80 | 2015-09-01 | 2017-03-27 |
| Pilot Study: Hepatoprotective Role of SMOFlipid® Used in Short-term Parenteral Nutrition in an Onco-Hematology Pediatric Population Smoflipid, Médialipides - Dietary and Nutritional Therapies | Phase 4 | Completed | Centre Hospitalier Universitaire de Nice | 9 | 2015-06-01 | 2017-04-13 |
| Preventing Cholestasis Using SMOFLipid® SMOFLIPID, INTRALIPID - Cholestasis, Psychomotor Disorders, Developmental | Phase 4 | Completed | Medical University of Vienna | 230 | 2012-06-01 | 2018-01-09 |
| Crossover Study on the Effect of Omegaven in Combination With Different Lipid Emulsions in Home Parenteral Nutrition ClinOleic (baseline), ClinOleic + Omegaven, Lipoplus (baseline) - Parenteral Nutrition | Phase 4 | Completed | General University Hospital, Prague | 24 | 2012-01-15 | 2017-05-11 |
| Reduction of Neonatal Parenteral Nutrition Associated Cholestasis Through Lipid Emulsions SMOFlipid, Lipofundin - Intrahepatic, Cholestasis | Phase 4 | Terminated | Centro Hospitalar de Lisboa Central | 52 | 2011-08-01 | 2017-07-13 |
| Influence of of a Lipid Emulsion on Inflammatory Response and Hepatic Function SMOFlipid®, 2-ClinOleic 20%® - Inflammatory Response, Hepatic Function | Phase 4 | Completed | Klinikum Ludwigshafen | 42 | 2006-12-01 | 2009-12-03 |
Hyperphagia (6) · Child Nutrition Disorders (2) · Malnutrition (2) · Premature Birth (2) · Cholestasis (1) · Cholestasis, Intrahepatic (1) · Intestinal Failure (1) · Neonatal Sepsis (1) · Neurotoxicity Syndromes (1) · Psychomotor Disorders (1) · Sepsis (1) · Short Bowel Syndrome (1)
Fresenius Kabi (2) · Centre Hospitalier Universitaire de Nice (1) · Centro Hospitalar de Lisboa Central (1) · General University Hospital, Prague (1) · Hospices Civils de Lyon (1) · Klinikum Ludwigshafen (1) · Mansoura University (1) · Mansoura University Children Hospital (1) · Mayo Clinic (1) · Medical University of Vienna (1) · Shanghai Jiao Tong University School of Medicine (1)
United States (3) · Egypt (2) · France (2) · Austria (1) · Czechia (1) · Germany (1)
Jeffrey Rudolph, MD (2) · Amr M Yassen, MD (1) · Andreas Repa, MD (1) · Frantisek Novak, MD, PhD (1) · Luis Pereira-da-Silva, MD, PhD (1) · Manpreet S Mundi (1) · Nadja Haiden, MD (1) · Swen N. Piper, Dr. med. (1) · Yahya M Wahba, MD (1) · Ying Wang, Phd (1)
PMID 20393276, PMID 10022591, PMID 11906641, PMID 12710654, PMID 15269615, PMID 15585684, PMID 16254497, PMID 16632649, PMID 18310188, PMID 19571170, PMID 19687773, PMID 20398379, PMID 22319539, PMID 22683686, PMID 22942104, PMID 23398476, PMID 24961544, PMID 25722954, PMID 26146621, PMID 26630252, PMID 28630687, PMID 29269199, PMID 29415837, PMID 31030946, PMID 32590001, PMID 36257349