NCT03857646

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 0 Days – 8 Days
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Prematurity

Interventions

Type	Name	Description
DRUG	Intralipid, 20% Intravenous Emulsion	Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate.
DRUG	Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid	Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate.

Timeline

• Start date: 2019-03-02
• Primary completion: 2020-06-11
• Completion: 2020-06-11
• First posted: 2019-02-28
• Last updated: 2025-03-03
• Results posted: 2025-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study