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

Eligibility

Eligible Ages
All ages
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

ArmDescriptionAssigned 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 lipid dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the lipid 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. Investigational or control drug will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. The lipid emulsions will be infused into a central or peripheral vein.
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 lipid dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the lipid 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. Investigational or control drug will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. The lipid emulsions will be infused into a central or peripheral vein.

Recruiting Locations

Vanderbilt Children's Hospital
Nashville, Tennessee 37345
Contact:
William Walsh, MD

More Details

NCT ID
NCT02579265
Status
Recruiting
Sponsor
Fresenius Kabi

Study Contact

John F Stover, MD
+49 6172 686
john.stover@fresenius-kabi.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.