NCT04586608

Investigation of Administration of MCT/ω-3 Fatty Acids is Towards Anti-inflammatory Related Fatty Acid Profile in Preterm Neonates.

Administration of an Intravenous Fat Emulsion Enriched With MCT/ω-3 Fatty Acids is Beneficial Towards Anti-inflammatory Related Fatty Acid Profile in Preterm Neonates: a Randomized, Double-blind Clinical Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Iaso Maternity Hospital, Athens, Greece · Academic / Other
• Sex: All
• Age: 0 Days – 2 Days
• Healthy volunteers: Not accepted

Summary

Intravenous administration of pure soybean oil emulsions high in linoleic acid may lead to inflammation and lipid peroxidation in preterm neonates. The aim of the present study was to investigate the effects of a medium-chain triglyceride (MCT)/n-3 polyunsaturated fatty acid (PUFA)-enriched intravenous fat emulsion (IVFE) on plasma fatty acid (FA) profile in preterm neonates. Methods: In this double-blind randomized study, 92 preterm neonates (gestational age \<32 weeks, birth weight \<1500g) were assigned to receive either MCT/n-3 PUFA-enriched IVFE (Intervention Group) or soybean oil-based IVFE (Control Group). Neonates' parents gave their informed written consent for inclusion in the study. Levels of FAs were measured at baseline (day 0) and day 15 of parenteral nutrition with gas-chromatography mass-spectrometry.

Conditions

• Premature Birth

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	MCT/ω-3 fatty acids	The provision of ω-3 fatty acids to premature neonates in the Parenteral Nutrition.
DIETARY_SUPPLEMENT	soybean oil-based IVFE	soybean oil-based IVFE

Timeline

• Start date: 2018-02-15
• Primary completion: 2020-02-15
• Completion: 2020-05-15
• First posted: 2020-10-14
• Last updated: 2020-10-19

Locations

1 site across 1 country: Greece