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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Development of Parenteral Nutrition-Associated Liver Disease and Other Adverse Effects in Neonates Receiving
Lindsey Stramara1, Lela Hernandez1, Barry T Bloom2
1Wesley Children's Hospital, Wichita, Kansas, USA.
Insights
A four-oil lipid emulsion (ILE) may help prevent parenteral nutrition-associated liver disease (PNALD) in neonates. This study found a lower incidence of PNALD in infants receiving the four-oil ILE compared to a soybean-oil ILE.
Area of Science:
- Neonatal intensive care
- Hepatology
- Nutritional support
Background:
- Parenteral nutrition-associated liver disease (PNALD) is a concern in neonates.
- Intravenous lipid emulsions (ILEs) are a known risk factor for PNALD.
- SMOFlipid, a four-oil ILE, is used for PNALD reversal, but its preventive role is unclear.
Purpose of the Study:
- To evaluate the safety of a four-oil ILE in neonates.
- To compare the effectiveness of a four-oil ILE versus a soybean-oil ILE in preventing PNALD.
Main Methods:
- Observational, cohort, comparative safety study.
- Matched 333 neonates receiving a four-oil ILE with 999 neonates receiving a soybean-oil ILE.
- Primary outcome: incidence of PNALD (direct bilirubin > 2 mg/dL) after parenteral nutrition initiation.
Main Results:
- PNALD occurred in 1.8% of the four-oil ILE group and 3.6% of the soybean-oil ILE group.
- Relative risk for PNALD was 0.5 (95% CI, 0.21-1.18) for the four-oil ILE group.
- No significant difference in PNALD incidence, but a trend towards reduced risk was observed.
Conclusions:
- A four-oil ILE may possess a hepatoprotective effect in neonates.
- Further research is warranted to confirm the preventive role of four-oil ILEs in PNALD.
- This study suggests a potential benefit of four-oil ILEs in neonatal liver health.
Background:
Intravenous lipid emulsions (ILEs) are a risk factor for parenteral nutrition-associated liver disease (PNALD) in the neonatal population. Current literature supports the use of SMOFlipid (4-oil ILE), a fish oil-containing lipid emulsion, for the reversal of PNALD. However, there is little information about the use of 4-oil ILEs for preventing PNALD. The purpose of this study is to examine the safety of a 4-oil ILE in neonates and its effectiveness in preventing PNALD among neonates compared with Intralipid (a soybean-oil, SO-ILE).
Methods:
This is an observational, cohort, comparative safety study, conducted in a level III neonatal intensive care unit. Participants include neonates who received a 4-oil ILE in their parenteral nutrition (PN) formula, who were matched with historical data of patients who received an SO-ILE, in a 1:3 fashion (4-oil ILE:SO-ILE). The primary outcome of this study is the presence of PNALD (defined as direct bilirubin > 2 mg/dL) after initiation of PN.
Results:
A total of 1332 participants (333 4-oil ILE vs 999 SO-ILE) were included in the data analysis, and PNALD was found to occur in 1.8% of patients in the 4-oil ILE group and 3.6% of patients in the SO-ILE group (Relative risk (RR) 0.5; 95% CI, 0.21-1.18).
Conclusion:
The decrease in the incidence of PNALD among the 4-oil ILE group compared with the SO-ILE group indicates a 4-oil ILE may have a hepatoprotective effect.
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