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

Fresenius Kabi

Status and phase: Terminated; Phase 3

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

Treatments: Drug: Smoflipid 20% (investigational lipid for parenteral nutrition); Drug: Intralipid® 20%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02579265

SMOF-018-CP3

Details and patient eligibility

About

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.

Enrollment: 204 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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204 participants in 2 patient groups

Smoflipid 20%

Experimental group

Description:

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".

Treatment:

Drug: Smoflipid 20% (investigational lipid for parenteral nutrition)

Intralipid® 20%

Active Comparator group

Description:

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".

Treatment:

Drug: Intralipid® 20%