Safety and Efficacy of a Composite Lipid Emulsion with Fish Oil in Hospitalized Neonates and Infants Requiring Prolonged Parenteral Nutrition - A Randomized, Double-Blind, Multicenter, Controlled Trial
CO-ILE was associated with a possible lower risk of cholestasis and significantly lower conjugated bilirubin concentration at the end of the initial treatment phase in high-risk neonates and infants as compared with patients treated with SOLE. In summary, these data indicate that CO-ILE can be considered safe and may be preferable over SOLE in high-risk neonates. This trial was registered at clinicaltrials.gov as NCT02579265.
Authors
- Jeffrey A. Rudolph (ORCID: https://orcid.org/0000-0002-1763-7927)
- Steven A. Abrams (ORCID: https://orcid.org/0000-0003-4972-9233)
- Darla Shores (ORCID: https://orcid.org/0000-0002-0551-7880)
- Katherine R. McCallie
- Amy B. Hair (ORCID: https://orcid.org/0000-0001-7570-0667)
- Daniel T. Robinson (ORCID: https://orcid.org/0000-0003-2450-9680)
- Ann Anderson‐Berry (ORCID: https://orcid.org/0000-0002-8496-2543)
- K Ernst (ORCID: https://orcid.org/0000-0001-6164-4502)
- Joanne Lai (ORCID: https://orcid.org/0000-0003-0974-8210)
- Jörn-Hendrik Weitkamp (ORCID: https://orcid.org/0000-0002-6654-4823)
- Jaehwan Kim (ORCID: https://orcid.org/0000-0002-6152-2924)
- Brian Lane
- Orly Levit
- Maria R. Mascarenhas
- Con Yee Ling (ORCID: https://orcid.org/0009-0006-4288-2584)
Institutions
- Cincinnati Children's Hospital Medical Center (US)
- Yale New Haven Hospital (US)
- Primary Children's Hospital (US)
- Children's Hospital of Philadelphia (US)
- Johns Hopkins University (US)
- Palo Alto University (US)
- Johns Hopkins Medicine (US)
- Rady Children's Hospital-San Diego (US)
- Monroe Carell Jr. Children's Hospital (US)
- Children's Hospital of Oklahoma (US)
- Lurie Children's Hospital (US)
- Perinatal Institute (GB)
- Children's Hospital of Pittsburgh (US)
- Texas Children's Hospital (US)
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University
- University of Nebraska Medical Center (US)
- The University of Texas at Austin (US)
- Stanford University (US)
- Icahn School of Medicine at Mount Sinai (US)
Publication Details
- Journal
- Journal of Nutrition
- Published
- 2024-10-05
- DOI
- https://doi.org/10.1016/j.tjnut.2024.10.005
- Citations
- 2
- Primary Topic
- Clinical Nutrition and Gastroenterology
- Type
- article
- Field-Weighted Citation Impact
- 0.62
Funders
- Fresenius Kabi
- U.S. Food and Drug Administration