TY - JOUR
T1 - Low-dose parenteral soybean oil for the prevention of parenteral nutrition-associated liver disease in neonates with gastrointestinal disorders
AU - Calkins, Kara L.
AU - Havranek, Thomas
AU - Kelley-Quon, Lorraine I.
AU - Cerny, Laura
AU - Flores, Martiniano
AU - Grogan, Tristan
AU - Shew, Stephen B.
N1 - Publisher Copyright:
© The American Society for Parenteral and Enteral Nutrition.
PY - 2017/3/1
Y1 - 2017/3/1
N2 - 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.
AB - 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.
KW - cholestasis
KW - gastrointestinal disorders
KW - neonates
KW - parenteral nutrition
KW - soybean oil
UR - http://www.scopus.com/inward/record.url?scp=85019039799&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85019039799&partnerID=8YFLogxK
U2 - 10.1177/0148607115588334
DO - 10.1177/0148607115588334
M3 - Article
C2 - 26024828
AN - SCOPUS:85019039799
SN - 0148-6071
VL - 41
SP - 404
EP - 411
JO - Journal of Parenteral and Enteral Nutrition
JF - Journal of Parenteral and Enteral Nutrition
IS - 3
ER -