Vanderbilt Clinical Trials

Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants

Purpose

To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during the first 28 days of study treatment, confirmed by a second sample collected 7 days after the first sample.

Condition

Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days

Eligibility

Eligible Ages: Over 0 Weeks
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Neonates and infants, expected to require parenteral nutrition (PN) for 28 days - 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

Conjugated bilirubin > 0.6 mg/dL - 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

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental 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".	Drug: 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. Other names: Smoflipid 20% (lipid injectable emulsion)
Active Comparator 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".	Drug: 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 names: Intralipid® 20% (a 20% intravenous fat emulsion)

More Details

Status: Terminated
Sponsor: Fresenius Kabi