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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04586608

Acronym

MCT/ω-3 FA

Enrollment

Registered

2020-10-14

Start date

2018-02-15

Completion date

2020-05-15

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

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.

Interventions

DIETARY_SUPPLEMENTMCT/ω-3 fatty acids

The provision of ω-3 fatty acids to premature neonates in the Parenteral Nutrition.

DIETARY_SUPPLEMENTsoybean oil-based IVFE

soybean oil-based IVFE

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

0 Days to 2 Days

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026