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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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000337279
Enrollment
40
Registered
2009-05-22
Start date
2009-07-14
Completion date
2011-10-19
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Fat emulsions are an essential part of parenteral nutrition (PN) combining a high energy load with an essential fatty acid (EFA) intake.The primary purpose of this study is to test the safety and efficacy of new fish oil based intravenous fat emulsion (SMOFlipid) as compared to traditional olive oil based intravenous fat emulsion (Clinoleic). This study will specifically look at plasma and red cell fatty acid levels particularly Docosahexaenoic acid (DHA) which plays an important role in development and vision of newborn babies and also oxidative strss levels (F2-isoprostanes) before and after the intervention in a randomised controlled trial.

Interventions

SMOFlipid intravenous lipid emulsion (soy oil, MCT(medium chain triglycerides), olive oil and fish oil based). Dose: 1g/kg on day 1 of study, 2g/kg on day2 and 3g/kg on day3 to day 7 of study

Sponsors

Princess Margaret Hospsital for Children
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
1 Days to 7 Days
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026