Journal
JOURNAL OF PARENTERAL AND ENTERAL NUTRITION
Volume 41, Issue 3, Pages 404-411Publisher
SAGE PUBLICATIONS INC
DOI: 10.1177/0148607115588334
Keywords
neonates; parenteral nutrition; cholestasis; soybean oil; gastrointestinal disorders
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Funding
- NIH [K12HD00140, T32GM75776-6, K08HD052885]
- Today's and Tomorrow's Children Fund, Mattel Children's Hospital, University of California, Los Angeles
- National Center for Advancing Translational Sciences through UCLA CTSI [UL1TR000124]
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Background: Neonates with gastrointestinal disorders (GDs) are at high risk for parenteral nutrition-associated liver disease (PNALD). Soybean-based intravenous lipid emulsions (S-ILE) have been associated with PNALD. This study's objective was to determine if a lower dose compared with a higher dose of S-ILE prevents cholestasis without compromising growth. Materials and Methods: This multicenter randomized controlled pilot study enrolled patients with GDs who were 5 days of age to a low dose (similar to 1 g/kg/d) (LOW) or control dose of S-ILE (similar to 3 g/kg/d) (CON). The primary outcome was cholestasis (direct bilirubin [DB] >2 mg/dL) after the first 7 days of age. Secondary outcomes included growth, PN duration, and late-onset sepsis. Results: Baseline characteristics were similar between the LOW (n = 20) and CON groups (n = 16). When the LOW group was compared with the CON group, there was no difference in cholestasis (30% vs 38%, P = .7) or secondary outcomes. However, mean +/- SE DB rate of change over the first 8 weeks (0.07 +/- 0.04 vs 0.3 +/- 0.09 mg/dL/wk, P = .01) and entire study (0.008 +/- 0.03 vs 0.2 +/- 0.07 mg/dL/wk, P = .02) was lower in the LOW group compared with the CON group. Conclusion: In neonates with GDs who received a lower dose of S-ILE, DB increased at a slower rate in comparison to neonates who received a higher dose of S-ILE. Growth was comparable between the groups. This study demonstrates a need for a larger, randomized controlled trial comparing 2 different S-ILE doses for cholestasis prevention in neonates at risk for PNALD.
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