Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants
NCT ID: NCT02579265
Last Updated: 2022-01-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
204 participants
INTERVENTIONAL
2015-12-31
2020-04-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Smoflipid 20%
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Smoflipid 20% (investigational lipid for parenteral nutrition)
Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
Intralipid® 20%
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Intralipid® 20%
Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
Interventions
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Smoflipid 20% (investigational lipid for parenteral nutrition)
Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
Intralipid® 20%
Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Postmenstrual age ≥ 24 weeks
* Birth weight ≥ 750g
* Gastroschisis, duodenal, jejunal or ileal atresia, volvulus, spontaneous intestinal perforation or necrotizing enterocolitis (Bell's stage 2B or higher)
* At least 80% of nutritional needs at baseline received by PN
* Signed and dated informed consent obtained from at least one parent or legal guardian
Exclusion Criteria
* Any known pre-, intra- or posthepatic complication increasing conjugated bilirubin levels \> 0.6, mg/dL during study participation
* Suspected liver disease or liver damage based on either aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) exceeding 2.5x upper limit of normal range
* Active bloodstream infection demonstrated by positive blood culture at screening
* Cystic fibrosis
* Meconium ileus
* Serum triglyceride levels \> 250 mg/dL
* Cyanotic congenital heart defect
* Severe renal failure with serum creatinine \> 2.0 mg/dL
* History of shock requiring vasopressors
* Anasarca
* Extracorporeal Membrane Oxygenation (ECMO)
* Known inborn errors of metabolism
* Known congenital viral infection
* Unlikely to survive longer than 28 days
* Known hypersensitivity to fish-, egg-, soya- or peanut protein or to any of the active substances or excipients
0 Weeks
ALL
No
Sponsors
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Fresenius Kabi
INDUSTRY
Responsible Party
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Principal Investigators
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Steven A Abrams, MD
Role: PRINCIPAL_INVESTIGATOR
Dell Medical School at The University of Texas at Austin
Locations
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Lucile Packard Children's Hospital
Palo Alto, California, United States
UC San Diego Medical Center
San Diego, California, United States
Rady Children's Hospital San Diego
San Diego, California, United States
Yale - New Haven Children's Hospital
New Haven, Connecticut, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Mount Sinai Hospital
New York, New York, United States
Steven & Alexandra Cohen Children's Medical Center of NY
New York, New York, United States
The Children's Hospital at OU Medical Center
Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
Texas Children's Hospital
Houston, Texas, United States
Countries
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References
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Abrams SA, Ernst KD, Weitkamp JH, Mascarenhas M, Anderson-Berry A, Rudolph J, Ling CY, Robinson DT, Shores D, Hair AB, Lai J, Lane B, McCallie KR, Levit O, Kim JH. Safety and Efficacy of a Composite Lipid Emulsion with Fish Oil in Hospitalized Neonates and Infants Requiring Prolonged Parenteral Nutrition - A Randomized, Double-Blind, Multicenter, Controlled Trial. J Nutr. 2024 Dec;154(12):3615-3625. doi: 10.1016/j.tjnut.2024.10.005. Epub 2024 Oct 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SMOF-018-CP3
Identifier Type: -
Identifier Source: org_study_id
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