Low‐Dose Parenteral Soybean Oil for the Prevention of Parenteral Nutrition–Associated Liver Disease in Neonates With Gastrointestinal Disorders |
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| Authors: | Kara L. Calkins MD Thomas Havranek MD Lorraine I. Kelley‐Quon MD MSHS Laura Cerny MD Martiniano Flores MS Tristan Grogan MS Stephen B. Shew MD |
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| Affiliation: | 1. David Geffen School of Medicine, University of California, Los Angeles, and Mattel Children's Hospital at UCLA, Department of Pediatrics, Division of Neonatology and Developmental Biology, Neonatal Research Center of the UCLA Children's Discovery and Innovation Institute, Los Angeles, California, USA;2. Department of Pediatrics, Division of Neonatology, St Louis University School of Medicine, Cardinal Glennon Children's Hospital, St Louis, Missouri, USA;3. Department of Pediatrics, Division of Neonatology, Albert Einstein College of Medicine, Bronx, New York, USA;4. Department of Surgery, Division of General Surgery, David Geffen School of Medicine, University of California, Los Angeles, California, USA;5. Department of Biostatistics, Fielding School of Public Health, University of California, Los Angeles, California, USA;6. Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, California, USA;7. Department of Surgery, Division of Pediatric Surgery, David Geffen School of Medicine, University of California, Los Angeles, California, USA |
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| Abstract: | 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 (~1 g/kg/d) (LOW) or control dose of S‐ILE (~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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| Keywords: | neonates parenteral nutrition cholestasis soybean oil gastrointestinal disorders |
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