Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Fresenius Kabi

Stanford Investigator(s):

Intervention(s):

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

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kari McCallie, MD
650-723-5711
Not Recruiting