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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

Year: 2024
Type: article
Abstract: 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.
DOI: 10.1016/j.tjnut.2024.10.005
Authors: Steven A Abrams, Kimberly D Ernst, Joern-Hendrik Weitkamp, Maria Mascarenhas, Ann Anderson-Berry, Jeffrey Rudolph, Con Y Ling, Daniel T Robinson, Darla Shores, Amy B Hair, Joanne Lai, Brian Lane, Katherine R McCallie, Orly Levit, Jae H Kim
Institutions: The University of Texas at Austin, Children's Hospital of Oklahoma, University of Oklahoma Health Sciences Center, University of Oklahoma, Monroe Carell Jr. Children's Hospital, Vanderbilt University Medical Center, Children's Hospital of Philadelphia, University of Pennsylvania, University of Nebraska Medical Center, Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Primary Children's Hospital, University of Utah, Northwestern University, Lurie Children's Hospital, Johns Hopkins University, Johns Hopkins Medicine, Johns Hopkins Hospital, Baylor College of Medicine, Texas Children's Hospital, Icahn School of Medicine at Mount Sinai, University of California San Diego, Rady Children's Hospital-San Diego, Stanford University, Yale University, Cincinnati Children's Hospital Medical Center, University of Cincinnati
Language: English
Field: Nursing
Open Access status: hybrid
Estimated APC paid: $5,100
OpenAlex ID: W4403154845
FWCI: 0.914
Cites: 28
Cited by: 4
Related to: 10