Efficacy and safety of a new fish oil based lipid emulsion (SMOFlipid) compared with olive oil based lipid emulsion (Clinoleic) in pre term (<30 weeks) neonates – a randomised controlled trial

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609001017213

Enrollment

Registered

2009-11-24

Start date

2009-11-30

Completion date

Unknown

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

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

Inclusion criteria

1) Preterm neonates (<30 weeks) admitted in the neonatal unit at King Edward Memorial Hospital for Women 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