Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition

Thammasat University

Status and phase: Completed; Phase 3

Conditions: Cholestasis

Treatments: Drug: pure soybean oil lipid emulsion; Drug: multicomponent lipid emulsion

Study type: Interventional

Funder types: Other

Identifiers

NCT02663453

MTU-EC-PE-1-033/56

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 44 patients

Sex: All

Ages: 24 to 30 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inborn infants with a gestational age of less than 30 weeks
• Who required parenteral nutrition for at least 7 days

Exclusion criteria

• Evidence of congenital infection
• Perinatal asphyxia
• Congenital anomalies
• Severe IVH
• Thrombocytopenia
• Shock or circulation failure
• Renal or hepatic disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups

study group

Experimental group

Description:

multicomponent lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1gm/kg/day within 24 hours after birth; 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.The macronutrients and micronutrients were provided using the same products in both groups.

Treatment:

Drug: multicomponent lipid emulsion

control group

Active Comparator group

Description:

pure soybean oil lipid emulsion(intralipid) was administered at a dose of 1gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.

Treatment:

Drug: pure soybean oil lipid emulsion