SMOFLipid vs Clinoleic - randomised controlled trial

Effect of fish oil based lipid emulsion (SMOFlipid) compared with olive oil based lipid emulsion (Clinoleic) on omega-3 fatty acid levels in preterm (<30 weeks) neonates – a randomised controlled trial.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000883314

Enrollment

Registered

2017-06-16

Start date

2017-06-28

Completion date

2018-09-28

Last updated

2017-07-04

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

Conditions

None listed

Brief summary

Survival of high-risk premature babies has improved significantly in the last 20 years. Feeding intolerance is a common issue seen in extremely preterm babies, and in those with conditions such as gastroschrisis, definite necrotising enterocolitis, and short bowel syndrome. Long-term support with parenteral nutrition (PN) is crucial for these babies to provide optimal nutrition at a critical stage of development. Lipid formulations are an important component of PN, being a good source of energy, essential fatty acids (EFA), and also of long chain polyunsaturated fatty acids (LC-PUFAs). In recent years, focus on omega-3 fatty acids has stipulated that increased omega-3 LCPUFA, mainly docosahexanoic acid (DHA), supplementation may have extra beneficial effects for extremely premature babies who have higher rates and severity of neonatal diseases of prematurity, such as late onset sepsis, necrotising enterocolitis, respiratory diseases of the newborn, and as such have a higher inflammatory status. A recent study by Deshpande et al. (2014) examined the use of SMOFLipid, a lipid emulsion with higher omega-3 content, compared to ClinOleic, a lipid emulsion with low omega-3 content, and found that eicosapentanoic acid (EPA) levels, and F2-isoprostane (an inflammatory marker) were slightly decreased. However docosahexanoic acid (DHA) levels were found to be similar. Soybean lipid emulsions are associated with parenteral nutrition-associated cholestasis and liver disease and studies with using pure fish oil based emulsion showed improvement in the cholestasis. The effect on phytosterol levels by lipid emulsions has not previously been studied in extremely premature neonates. This randomised controlled trial will compare the fatty acid levels, phytosterol levels, liver function tests and conjugated bilirubin in both groups. We hypothesis that in very preterm neonates born before 29 weeks, fish oil based lipid emulsion will result in higher omega-3 fatty acids levels as compared to standard olive oil based lipid emulsion.

Interventions

Arm 1 - SMOFLipid 20% is a lipid formulation that contains 30% Soybean Oil, 30% Coconut Oil (Medium chain triglycerides), 25% Olive oil and 15% Fish Oil. Babies randomised to the SMOFLipid group will receive 2 grams of lipid on day 1 intravenously as part of parenteral nutrition, increasing to 3 grams of lipid on day 2 until day 7.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

1 Days to 7 Days

Healthy volunteers

Inclusion criteria

Babies born less than 30 weeks gestation

Exclusion criteria

- Blood culture positive sepsis - Thrombocytopenia (Platelet count <130 X 109/L) - Unconjugated hyperbilirubinemia (requiring exchange transfusion) - Metabolic disorders including lactic and/or uncompensated acidosis - No parenteral consent - Administration of IV lipid infusion prior to study - Postnatal age > 7 days

Outcome results