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.

Autor:	Abrams SA; Department of Pediatrics, Dell Medical School at the University of Texas-Austin, Austin, TX, United States. Electronic address: sabrams@austin.utexas.edu., Ernst KD; Division of Neonatal-Perinatal Medicine, The University of Oklahoma Children's Hospital, Oklahoma City, OK, United States., Weitkamp JH; Department of Pediatrics, Mildred Stahlman Divison of Neonatology, Vanderbilt University Medical Center, Monroe Carrol Jr. Children's Hospital, Nashville, TN, United States., Mascarenhas M; Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, and Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, PA, United States., Anderson-Berry A; Department of Pediatrics, University of Nebraska Medical Center, Omaha, NE, United States., Rudolph J; Division of Gastroenterology, Department of Pediatrics, Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA, United States., Ling CY; Department of Pediatrics, University of Utah and Division of Neonatology at Primary Children's Hospital, Salt Lake City, UT, United States., Robinson DT; Department of Pediatrics, Northwestern University Feinberg School of Medicine and Division of Neonatology, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, United States., Shores D; Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, MD, United States., Hair AB; Division of Neonatology, Department of Pediatrics, Baylor College of Medicine, Texas Children's Hospital, Houston, TX, United States., Lai J; Department of Pediatric Gastroenterology, Susan and Leonard Feinstein IBD Clinical Center, Icahn School of Medicine at Mount Sinai, New York, NY, United States., Lane B; Division of Neonatology, Departments of Pediatrics, University of California, San Diego and Rady Children's Hospital San Diego, San Diego, CA, United States., McCallie KR; Division of Neonatal and Developmental Medicine, Department of Pediatrics, Stanford University, Palo Alto, CA, United States., Levit O; Neonatal-Perinatal Medicine, General Neonatology, Yale New Haven Children's Hospital, New Haven, CT, United States., Kim JH; Perinatal Institute, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, United States.
Jazyk:	angličtina
Zdroj:	The Journal of nutrition [J Nutr] 2024 Oct 05. Date of Electronic Publication: 2024 Oct 05.
DOI:	10.1016/j.tjnut.2024.10.005
Abstrakt:	Background: Intravenous lipids are critical to the care of extremely premature and other high-risk infants. Objectives: This study evaluated safety and efficacy of parenteral nutrition (PN) with composite intravenous lipid emulsion (CO-ILE) with fish oil compared with pure soybean oil lipid emulsion (SOLE). Methods: Randomized, controlled, double-blind, multicenter study (NCT02579265) in neonates/infants anticipated to require ≥28 d of PN due to gastrointestinal malformations or injury. Duration of the initial and extended treatment phase was 28 d and 84 d, respectively (for patients with PN indication after day 28). Results: Eighty-three patients (mean postnatal age 11.4 d, 54 preterm) received CO-ILE and 78 patients received SOLE (mean postnatal age 8.3 d, 59 preterm). Thirty-three patients per group completed 28 d of treatment. Risk of having conjugated bilirubin values >2 mg/dL confirmed by a second sample 7 d after the first during the initial treatment phase (primary outcome) was 2.4% (2 of 83) with CO-ILE and 3.8% (3 of 78) with SOLE (risk ratio: 0.59; 95% confidence interval [CI]: 0.09, 3.76). Between days 29 and 84, the number of patients with confirmed conjugated bilirubin values >2 mg/dL did not increase in the CO-ILE group (n = 2) and increased in the SOLE group (n = 9). At the end of the initial treatment phase, conjugated bilirubin concentrations were 45.6% lower under CO-ILE than under SOLE (P = 0.006). There was no clinical or laboratory evidence of essential fatty acid deficiency in patients in the CO-ILE group. Median time to discharge alive was 56.7 d and 66.4 d with CO-ILE and SOLE, respectively (hazard ratio: 1.16; 95% CI: 0.81, 1.68). Conclusions: 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. Competing Interests: Conflict of interest Steven Abrams’ institution received support from Fresenius Kabi for his time and effort as principal investigator of this study. Daniel Robinson is an institutional principal investigator, with no salary funding, for a consortium database sponsored by Mead Johnson Nutrition; previously received compensation as a member of the Data Safety Monitoring Board for a clinical investigation sponsored by Fresenius Kabi; and is a consultant for Baxter. Joern-Hendrik Weitkamp serves as consultant for Roche Diagnostics Operations, Inc. All other authors report no conflicts of interest. The institutions of the authors each received institutional research support from Fresenius Kabi for clinical conduct of the trial. (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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