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Updated: Jun 23, 2026
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Effects of mixed oil emulsion on short-term clinical outcomes in premature infants: A prospective, multicenter,
Qing Yang1,2,3, Juan Kong4, Rui-Miao Bai5
1Department of Neonatology, Women and Children's Hospital, School of Medicine, Xiamen University, Xiamen, 361003, China.
Insights
The study found that SMOF lipid emulsion reduced bilirubin and triglyceride levels in premature infants. SMOF also decreased the incidence of parenteral nutrition-associated cholestasis and metabolic bone disease, especially in infants born before 28 weeks.
Area of Science:
- Neonatology
- Pediatric Nutrition
- Clinical Pharmacy
Background:
- Premature infants (VPIs or VLBWIs) require specialized nutritional support, including intravenous lipid emulsions.
- Optimizing lipid formulations is crucial for improving clinical outcomes and reducing complications in vulnerable neonates.
Purpose of the Study:
- To compare the clinical effects of medium-chain triglycerides/long-chain triglycerides (MCT/LCT) versus a mixed lipid emulsion (soybean oil, medium-chain triglycerides, olive oil, and fish oil - SMOF) in VPIs or VLBWIs.
- To provide evidence-based recommendations for the optimal use of intravenous lipid emulsions in this population.
Main Methods:
- A prospective, multicenter randomized controlled study involving 465 VPIs or VLBWIs.
- Infants were randomly assigned to either the MCT/LCT group (n=231) or the SMOF group (n=234).
- Clinical features, biochemical markers, nutrition support, and complications were analyzed and compared between groups.
Main Results:
- The SMOF group showed significantly lower incidences of elevated total bilirubin (TB), direct bilirubin (DB), alkaline phosphatase (ALP), and triglycerides (TG) compared to the MCT/LCT group.
- In infants born before 28 weeks, the SMOF group had lower rates of parenteral nutrition-associated cholestasis (PNAC) and metabolic bone disease of prematurity (MBDP).
- Multivariate analysis confirmed that SMOF reduced the risk of PNAC and MBDP.
Conclusions:
- SMOF lipid emulsion is associated with improved lipid tolerance and reduced hyperbilirubinemia and hypertriglyceridemia in VPIs or VLBWIs.
- SMOF demonstrates a significant benefit in reducing the incidence of PNAC and MBDP, particularly in extremely preterm infants (<28 weeks gestation).
- These findings support the use of SMOF as a potentially more beneficial lipid formulation for specific groups of premature infants.
Objective:
This study compared the clinical effects of two different lipid emulsions in premature infants with gestational age < 32 weeks (VPI) or birth weight < 1500 g (VLBWI) to provide an evidence-based medicine basis for optimizing intravenous lipid emulsion.
Methods:
This was a prospective multicenter randomized controlled study. A total of 465 VPIs or VLBWIs, admitted to the neonatal intensive care unit of five tertiary hospitals in China from March 1, 2021 to December 31, 2021, were recruited. All subjects were randomly allocated into two groups, namely, medium-chain triglycerides/long-chain triglycerides (MCT/LCT) group (n = 231) and soybean oil, medium-chain triglycerides, olive oil, and fish oil (SMOF) group (n = 234). Clinical features, biochemical indexes, nutrition support therapy, and complications were analyzed and compared between the two groups.
Results:
No significant differences were found in perinatal data, hospitalization, parenteral and enteral nutrition support between the two groups (P > 0.05). Compared with the MCT/LCT group, the incidence of neonates with a peak value of total bilirubin (TB) > 5 mg/dL (84/231 [36.4% vs. 60/234 [25.6%]), a peak value of direct bilirubin (DB) ≥ 2 mg/dL (26/231 [11.3% vs. 14/234 [6.0%]), a peak value of alkaline phosphatase (ALP) > 900 IU/L (17/231 [7.4% vs. 7/234 [3.0%]), and a peak value of triglycerides (TG) > 3.4 mmol/L (13/231 [5.6% vs. 4/234[1.7%]]) were lower in the SMOF group (P < 0.05). Univariate analysis showed that in the subgroup analysis of < 28 weeks, the incidence of parenteral nutrition-associated cholestasis (PNAC) and metabolic bone disease of prematurity (MBDP) were lower in the SMOF group (P = 0.043 and 0.029, respectively), whereas no significant differences were present in the incidence of PNAC and MBDP between the two groups at > 28 weeks group (P = 0.177 and 0.991, respectively). Multivariate logistic regression analysis revealed that the incidence of PNAC (aRR: 0.38, 95% confidence interval [CI]: 0.20-0.70, P = 0.002) and MBDP (aRR: 0.12, 95% CI: 0.19-0.81, P = 0.029) in the SMOF group were lower than that in the MCT/LCT group. In addition, no significant differences were recorded in the incidence of patent ductus arteriosus, feeding intolerance, necrotizing enterocolitis (Bell's stage ≥ 2), late-onset sepsis, bronchopulmonary dysplasia, intraventricular hemorrhage, periventricular leukomalacia, retinopathy of prematurity and extrauterine growth retardation between the two groups (P > 0.05).
Conclusions:
The application of mixed oil emulsion in VPI or VLBWI can reduce the risk of plasma TB > 5 mg/dL, DB ≥ 2 mg/dL, ALP > 900 IU/L, and TG > 3.4 mmol/L during hospitalization. SMOF has better lipid tolerance, reduces the incidence of PNAC and MBDP, and exerts more benefits in preterm infants with gestational age < 28 weeks.
