The purpose of this study is to compare the effects of a multicomponent lipid emulsion containing 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, and 15% fish oil with a conventional pure soybean oil lipid emulsion on the incidence of neonatal cholestasis, infant growth, infant morbidity and the biochemical assessment of liver enzymes.
Intravenous lipid emulsions are the major sources of non-protein energy and provision of required essential fatty acids. The reference lipid emulsion, widely used for many years, is prepared from soybean oil, which is rich in omega 6 polyunsaturated fatty acids and phytosterols that contribute to hepatotoxicity and their metabolites result in pro-inflammatory eicosanoid production. Existing evidence strongly supports a pathogenetic role of inflammation and oxidative stress on parenteral nutrition associated liver disease. Subsequent development of lipid emulsions has focused on reducing the amount of soybean oil and replacing it with other oils.Moreover the omega 3 fatty acids from fish oil are metabolized to anti-inflammatory eicosanoids which can prevent inflammatory responses. A novel multicomponent lipid emulsion may prevent liver injury, improve growth and decrease morbidity in preterm infants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
44
Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.
Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.
Incidence of Neonatal Cholestasis
direct bilirubin level of more than 2 mg/dL
Time frame: 3 months
Neonatal Morbidities
retinopathy of prematurity, bronchopulmonary dysplasia
Time frame: 4 months
Incidence of Extrauterine Growth Restriction (EUGR)
weight that is less than the tenth percentile for corrected gestational age by the time of discharge
Time frame: up to 24 weeks
Weight Gain
in-hospital weight gain at birth until discharge (gram/day)
Time frame: up to 24 weeks
Height Gain
in-hospital height gain at birth until discharge (cm/week)
Time frame: up to 24 weeks
Head Circumference Gain
in-hospital head circumference gain at birth until discharge (cm/week)
Time frame: up to 24 weeks
Assessment of Gamma Glutamyltranspeptidase (GGT)
blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration
Time frame: 3 month
Assessment of Alanine Aminotransferase (ALT)
blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration
Time frame: 3 month
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Assessment of Aspartate Aminotransferase (AST)
blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration
Time frame: 3 month