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

Not Applicable

Completed

• Conditions: Premature Birth
• Interventions: Dietary Supplement: soybean oil-based IVFE; Dietary Supplement: MCT/ω-3 fatty acids

• Registration Number: NCT04586608
• Lead Sponsor: Iaso Maternity Hospital, Athens, Greece

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-15
• Primary Completion: 2020-02-15
• Study Completion: 2020-05-15
• Status Verified: 2020-10
• Study First Submitted: 2020-10-08
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-14
• Last Update Submitted: 2020-10-14
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Preterm neonates with gestational age <32 weeks

• birth weight <1500 g
• admitted to a tertiary neonatal intensive care unit within 12 hours after birth

Exclusion Criteria

• anticipated needs for parenteral nutrition (PN) at ˃70% of total daily energy for <10 days evidence of intrauterine infection,
• perinatal asphyxia
• major congenital anomalies
• refusal of parental consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
soybean oil-based IVFE	soybean oil-based IVFE	soybean oil-based IVFE
active comparator	MCT/ω-3 fatty acids	-

Primary Outcome Measures

Name	Time	Method
Alterations on Metabolic Fatty Acid Profile of the Premature Neonates	two years	the detection of clinically significant differences in plasma n-3 PUFAs, n-6 PUFAs and EPA in the MCT/ω-3 PUFA-enriched IVFE group compared to the SO-IVFE group post intervention.; the detection of clinically significant differences in plasma n-3 PUFAs, n-6 PUFAs and EPA in the MCT/ω-3 PUFA-enriched IVFE group compared to the SO-IVFE group post intervention.

Trial Locations

Locations (1)

Panos Papandreou; 🇬🇷 Athens, Greece