Low-Dose Intravenous Soybean Oil Emulsion for Prevention of Cholestasis in Preterm Neonates

Area of Science:

• Neonatology
• Pediatric Gastroenterology
• Nutritional Support

Background:

• Premature infants require intravenous fat emulsions for essential fatty acids and calories.
• Soybean-based intravenous fat emulsions (S-IFE) dose is linked to parenteral nutrition (PN)-associated liver disease.
• Investigating low-dose S-IFE as a preventive strategy for cholestasis in preterm neonates is crucial.

Purpose of the Study:

• To determine if a low dose of soybean-based intravenous fat emulsions (S-IFE) is a safe and effective strategy to prevent cholestasis in preterm neonates.
• To compare the incidence of cholestasis and growth parameters between preterm infants receiving low-dose versus control-dose S-IFE.

Main Methods:

• A multicenter randomized controlled trial involving preterm infants (gestational age ≤29 weeks).
• Infants were randomized to receive either a low (1 g/kg/d) or control (approx. 3 g/kg/d) dose of S-IFE within 48 hours of life.
• Primary outcome: cholestasis defined by direct bilirubin levels at 28 days of life or full enteral feeds; secondary outcomes: growth, hospital stay, mortality, and morbidities.

Main Results:

• 136 neonates were enrolled; baseline characteristics were similar between the low and control groups.
• No significant difference in the primary outcome of cholestasis was observed (69% vs 63%; P = .45).
• While the low-dose group received less S-IFE and fewer total calories, growth parameters (weight, length, head circumference) were not significantly different between groups.

Conclusions:

• Low-dose S-IFE was not associated with a reduction in cholestasis in preterm neonates compared to the control dose.
• The study did not find a significant impact of low-dose S-IFE on infant growth parameters.
• Further research may be needed to explore optimal S-IFE dosing strategies for vulnerable preterm populations.