Low-Dose Intravenous Soybean Oil Emulsion for Prevention of Cholestasis in Preterm Neonates
Levit OL, Calkins KL, Gibson LC, Kelley-Quon L, Robinson DT, Elashoff DA, Grogan TR, Li N, Bizzarro MJ, Ehrenkranz RA
JPEN. Journal of parenteral and enteral nutrition · 35 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Clinical events such as disease or death
- Intake measured by
- Food provided by researchers
Who paid for it
- Funding
- Independent funding
- University or hospital
- Indiana Clinical and Translational Sciences Institute
- Government
- National Institutes of Health
- University or hospital
- University of California, Los Angeles
- Government
- U.S. Public Health Service
- Government
- National Institute of General Medical Sciences
- Government
- National Center for Advancing Translational Sciences
- Government
- Eunice Kennedy Shriver National Institute of Child Health and Human Development
- Government
- NCATS NIH HHS
- Government
- NICHD NIH HHS
- Government
- PHS HHS
- Government
- NIGMS NIH HHS
- Grants
- National Center for Advancing Translational Sciences (UL-1TR000124); Eunice Kennedy Shriver National Institute of Child Health and Human Development (K12 HD-034610); National Institutes of Health (T32G075776‐6); Eunice Kennedy Shriver National Institute of Child Health and Human Development (T32 HD-007094); Eunice Kennedy Shriver National Institute of Child Health and Human Development (K12HD00140); Eunice Kennedy Shriver National Institute of Child Health and Human Development (K12 HD001400); Indiana Clinical and Translational Sciences Institute (UL1TR000124); National Institute of General Medical Sciences (T32 GM075776); U.S. Public Health Service (T32G075776-6); University of California, Los Angeles (UL1 TR000124); National Institutes of Health (K12HD00140); National Institutes of Health (T32 HD007094)
Based on 11 listed funder(s).
Publication
- Published
- 2014-06-24 · JPEN J Parenter Enteral Nutr · vol. 40 · issue 3 · pp. 374–382
- Publisher
- Wiley
- Cited
- 53 citations · more than 95% of similar papers · 4.7× the field average
- Impact
- Top 10% most cited in its field
- References
- 23 works
- Access
- Open access (repository copy)
- Research areas
- Clinical Nutrition and Gastroenterology · Infant Nutrition and Health · Neonatal Respiratory Health Research
- Keywords
- Medicine, Calorie, Parenteral nutrition, Cholestasis, Gestational age, Enteral administration, Randomized controlled trial, Confidence interval, Gastroenterology, Internal medicine, Pediatrics, Pregnancy
- MeSH
- humans, cholestasis, bilirubin, soybean oil, fat emulsions, intravenous, treatment outcome, length of stay, gestational age, dose-response relationship, drug, infant, newborn, infant, premature, administration, intravenous
10 authors
From US
- Orly L. Levit · correspondingYale University
- Kara L. CalkinsUniversity of California, Los Angeles
- Leena Caroline GibsonUniversity of California, Los Angeles
- Lorraine I. Kelley‐QuonUniversity of California, Los Angeles
- Daniel T. RobinsonNorthwestern University
- David A. ElashoffUniversity of California, Los Angeles
Abstract
Background
Premature infants depend on intravenous fat emulsions to supply essential fatty acids and calories. The dose of soybean-based intravenous fat emulsions (S-IFE) has been associated with parenteral nutrition (PN)-associated liver disease. This study's purpose was to determine if low-dose S-IFE is a safe and effective preventive strategy for cholestasis in preterm neonates.
Materials and methods
This is a multicenter randomized controlled trial in infants with a gestational age (GA) ≤29 weeks. Patients <48 hours of life were randomized to receive a low (1 g/kg/d) or control dose (approximately 3 g/kg/d) of S-IFE. The primary outcome was cholestasis, defined as a direct bilirubin ≥15% of the total bilirubin at 28 days of life (DOL) or full enteral feeds, whichever was later, after 14 days of PN. Secondary outcomes included growth, length of hospital stay, death, and major neonatal morbidities.
Results
In total, 136 neonates (67 and 69 in the low and control groups, respectively) were enrolled. Baseline characteristics were similar for the 2 groups. When the low group was compared with the control group, there was no difference in the primary outcome (69% vs 63%; 95% confidence interval, -0.1 to 0.22; P = .45). While the low group received less S-IFE and total calories over time compared with the control group (P .2 for all).
Conclusion
Compared with the control dose, low-dose S-IFE was not associated with a reduction in cholestasis or growth.
Abstract via Europe PMC. Copyright remains with the authors or publisher.
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