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Safety and Efficacy of a Composite Lipid Emulsion with Fish Oil in Hospitalized Neonates and Infants Requiring
Steven A Abrams1, Kimberly D Ernst2, Joern-Hendrik Weitkamp3
1Department of Pediatrics, Dell Medical School at the University of Texas-Austin, Austin, TX, United States.
Insights
Composite intravenous lipid emulsion (CO-ILE) with fish oil may reduce cholestasis risk in high-risk infants compared to soybean oil lipid emulsion (SOLE). CO-ILE demonstrated lower conjugated bilirubin levels, suggesting it may be a preferable option.
Area of Science:
- Neonatalogy
- Pediatric Gastroenterology
- Nutritional Science
Background:
- Intravenous lipids are essential for extremely premature and high-risk infants.
- Parenteral nutrition (PN) is a critical supportive therapy.
Purpose of the Study:
- To compare the safety and efficacy of a composite intravenous lipid emulsion (CO-ILE) containing fish oil against a pure soybean oil lipid emulsion (SOLE).
- To evaluate the impact on cholestasis and overall clinical outcomes in neonates and infants requiring prolonged PN.
Main Methods:
- A randomized, controlled, double-blind, multicenter study involving neonates/infants needing at least 28 days of PN.
- Treatment duration included an initial 28-day phase and an extended 84-day phase.
- Primary outcome was the risk of confirmed conjugated hyperbilirubinemia (>2 mg/dL).
Main Results:
- The risk of confirmed conjugated hyperbilirubinemia was lower with CO-ILE (2.4%) versus SOLE (3.8%).
- CO-ILE showed significantly lower conjugated bilirubin concentrations (45.6% reduction) at the end of the initial treatment phase (P=0.006).
- No essential fatty acid deficiency was observed in the CO-ILE group; time to discharge alive was similar between groups.
Conclusions:
- CO-ILE appears to be associated with a reduced risk of cholestasis and lower conjugated bilirubin levels compared to SOLE in high-risk neonates.
- CO-ILE is considered safe and potentially preferable to SOLE for this vulnerable population.
- Further research may confirm the long-term benefits of CO-ILE in neonatal care.
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.
