The Effect of Lipid Emulsions on Free Fatty Acids and Free Bilirubin in Premature Newborns

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Prematurity

Treatments: Drug: Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid; Drug: Intralipid, 20% Intravenous Emulsion

Study type: Interventional

Funder types: Other

Identifiers

NCT03857646

HSC-MS-18-1000

Details and patient eligibility

About

The goal of this research study is to compare the levels of free fatty acids and free bilirubin between two intravenous lipid emulsion products in premature newborns.

Enrollment: 66 patients

Sex: All

Ages: Under 8 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• premature newborns (<32 weeks gestation, stratified <28 weeks versus >28 weeks) <8 days of age
• receiving lipid infusions <1 g/kg/day at enrollment
• anticipated to be treated with 3 g/kg/day for a minimum of 48 hours.

Exclusion criteria

• patients with direct hyperbilirubinemia >1.5 mg/dl
• with suspected sepsis meeting Systemic inflammatory response syndrome (SIRS) criteria
• undergoing treatment with a continuous infusion of morphine
• with a continuous infusion of pressors (dopamine, dobutamine, epinephrine, etc.)
• positive blood cultures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Intralipid

Other group

Treatment:

Drug: Intralipid, 20% Intravenous Emulsion

Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid

Other group

Treatment:

Drug: Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid