Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Fresenius Kabi
Age
0–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants
