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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)

Primary Purpose

Premature Birth

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
MCT/ω-3 fatty acids
soybean oil-based IVFE
Sponsored by
Iaso Maternity Hospital, Athens, Greece
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature Birth

Eligibility Criteria

0 Days - 2 Days (Child)All SexesDoes not accept 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

Sites / Locations

  • Panos Papandreou

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

active comparator

soybean oil-based IVFE

Arm Description

soybean oil-based IVFE

Outcomes

Primary Outcome Measures

Alterations on Metabolic Fatty Acid Profile of the Premature Neonates
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.

Secondary Outcome Measures

Full Information

First Posted
October 8, 2020
Last Updated
October 14, 2020
Sponsor
Iaso Maternity Hospital, Athens, Greece
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1. Study Identification

Unique Protocol Identification Number
NCT04586608
Brief Title
Investigation of Administration of MCT/ω-3 Fatty Acids is Towards Anti-inflammatory Related Fatty Acid Profile in Preterm Neonates.
Acronym
MCT/ω-3 FA
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
February 15, 2020 (Actual)
Study Completion Date
May 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iaso Maternity Hospital, Athens, Greece

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active comparator
Arm Type
Active Comparator
Arm Title
soybean oil-based IVFE
Arm Type
Other
Arm Description
soybean oil-based IVFE
Intervention Type
Dietary Supplement
Intervention Name(s)
MCT/ω-3 fatty acids
Intervention Description
The provision of ω-3 fatty acids to premature neonates in the Parenteral Nutrition.
Intervention Type
Dietary Supplement
Intervention Name(s)
soybean oil-based IVFE
Intervention Description
soybean oil-based IVFE
Primary Outcome Measure Information:
Title
Alterations on Metabolic Fatty Acid Profile of the Premature Neonates
Description
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.
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
2 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Panos Papandreou
City
Athens
ZIP/Postal Code
15123
Country
Greece

12. IPD Sharing Statement

Learn more about this trial

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

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