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

I

Iaso Maternity Hospital, Athens, Greece

Status

Completed

Conditions

Premature Birth

Treatments

Dietary Supplement: MCT/ω-3 fatty acids
Dietary Supplement: soybean oil-based IVFE

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

92 patients

Sex

All

Ages

Under 2 days old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

92 participants in 2 patient groups

active comparator
Active Comparator group
Treatment:
Dietary Supplement: MCT/ω-3 fatty acids
soybean oil-based IVFE
Other group
Description:
soybean oil-based IVFE
Treatment:
Dietary Supplement: soybean oil-based IVFE

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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