Efficacy and safety of a novel fish oil based lipid emulsion (SMOFlipid) compared with olive oil based lipid emulsion (Clinoleic) in term and near-term (>34 weeks) neonates – a randomised controlled trial

Completed

• Conditions: eonatal nutrition; Neonatal nutrition; Diet and Nutrition - Other diet and nutrition disorders; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12609000337279
• Lead Sponsor: Princess Margaret Hospsital for Children

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1) Term and near term neonates (>34 weeks) admitted in the neonatal unit at Princess Margaret Hospital and 2) Needing Parenteral Nutrition providing > 75% of energy expenditure requirements for at least 7 days

Exclusion Criteria

(1) Blood culture positive sepsis (2)Unconjugated hyperbilirubinemia (requiring exchange transfusion) (3) Metabolic disorders including lactic and/or uncompensated acidosis (4) No parenteral consent (5) Administration of Intravenous lipid infusion prior to study (6) Postnatal age > 7 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ong Chain-Poly Uunsaturated Fatty Acid (LC-PUFA) levels in plasma and Red cell membrane analysis[Baseline and Day 8 of the study];Plasma and Urinary F2-isoprostane level by GC/MS (Gas chrmatography/Mass spectrometry) method[Baseline and day 8 of the study]

Secondary Outcome Measures

Name	Time	Method
Phagocyte activation assay and cytokine production[Baseline and Day 8 of the study by pHRhodo assay and Enzyme-linked immunosorbent assay (ELISA)]