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Trial registered on ANZCTR


Registration number
ACTRN12617000883314
Ethics application status
Approved
Date submitted
17/02/2017
Date registered
16/06/2017
Date last updated
16/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
SMOFLipid vs Clinoleic - randomised controlled trial
Scientific title
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.
Secondary ID [1] 291172 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parenteral nutrition associated cholestasis and liver disease 302042 0
Late onset sepsis 302043 0
Chronic lung disease 302045 0
Patent ductus arteriosis 302046 0
Premature birth- Intra-ventricular haemorrhage 303669 0
Condition category
Condition code
Inflammatory and Immune System 301677 301677 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 301678 301678 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Reproductive Health and Childbirth 303068 303068 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 297170 0
Treatment: Drugs
Comparator / control treatment
Arm 2 - ClinOleic 20% is a lipid formulation that is derived from 20% Soybean oil and 80% Olive Oil. ClinOleic 20% is the current gold standard lipid formulation in use for <29 week gestation babies. Babies randomised to the ClinOleic 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.
Control group
Active

Outcomes
Primary outcome [1] 301076 0
Levels (Mean +/- SD) of LC-PUFAs in plasma and red cell membrane
Timepoint [1] 301076 0
Days 1 and 7 of lipid emulsion supplementation
Secondary outcome [1] 331671 0
Total enteral and parenteral energy intake (kcal/kg/day) assessed by review of medical records and neonatal database
Timepoint [1] 331671 0
During the study period (study day 1 to 8)
Secondary outcome [2] 331672 0
Incidence of triglyceridemia/hyperlipidemia (serum triglyceride level > 2.85 mmols/L)
Timepoint [2] 331672 0
Throughout trial monitoring period (Day 1 to day 8)
Secondary outcome [3] 331673 0
Number of episodes of blood culture positive sepsis
Timepoint [3] 331673 0
Time of admission to discharge.
Secondary outcome [4] 331674 0
Degree of intraventricular haemorrhage (IVH) by ultrasound
Timepoint [4] 331674 0
From day of admission till discharge
Secondary outcome [5] 331675 0
Duration of hospital stay
Timepoint [5] 331675 0
Until dischrge
Secondary outcome [6] 331676 0
Full blood count during treatment
Timepoint [6] 331676 0
study day 1 and 8. We will record the data if full blood count was conducted for clinical reason between day 2 to 8.
Secondary outcome [7] 331677 0
Serum conjugated bilirubin level
Timepoint [7] 331677 0
At 4 weeks of age and then every 2 weeks until discharge
Secondary outcome [8] 331678 0
Death
Timepoint [8] 331678 0
Before discharge
Secondary outcome [9] 331932 0
Serum liver enzymes AST, ALT and GGT
Timepoint [9] 331932 0
At 4 weeks of age and every 2 weeks there after until discharge.
Secondary outcome [10] 335997 0
Plasma Phytosterol levels
Timepoint [10] 335997 0
Days 1 and 7 of lipid emulsion supplementation

Eligibility
Key inclusion criteria
Babies born less than 30 weeks gestation
Minimum age
1 Days
Maximum age
7 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
We aim to recruit approximately 44 babies into the study.

Primary endpoint in the evaluation of efficacy of the lipid emulsions is plasma/RBC omega-3 LC-PUFA (EPA, DHA) levels (% of total fatty acids), omega-3 index. Based on the baseline levels of omega-3 LC-PUFA reported in previous trials (Deshpande et al. 2009 and Webb et al. 2008), sample sizes of 20 neonates per group allow detecting a difference of 1 standard deviation in plasma/RBC omega-3 LC-PUFA between the study groups with 90% power when using a univariate t-test with a significance level 0.05. Statistical power of the same magnitude will be attained for all continuously measured outcomes on LC-PUFA and their derivatives.

We anticipate a recruitment rate of 0-2 babies per week into the study, allowing for a 10% dropout rate.

References
Deshpande GC, Simmer K, Mori T, Croft K. Parenteral lipid emulsions based on olive oil compared with soybean oil in preterm (<28 weeks' gestation) neonates: a randomised controlled trial. J Pediatr Gastroenterol Nutr. 2009;49(5):619-625.

Webb AN, Hardy P, Peterkin M, Lee O, Shalley H, Croft KD, Mori TA, Heine RG, Bines JE. Tolerability and safety of olive oil-based lipid emulsion in critically ill neonates: a blinded randomized trial. Nutrition. 2008;24(11-12):1057-1064.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/06/2017
Actual
Date of last participant enrolment
Anticipated
28/09/2018
Actual
Date of last data collection
Anticipated
30/12/2018
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7481 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 15304 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 295614 0
University
Name [1] 295614 0
Nepean Medical Research Foundation, Sydney Medical School, University of Sydney
Country [1] 295614 0
Australia
Primary sponsor type
Hospital
Name
Nepean Hospital NICU
Address
Neonatal Intensive Care Unit
Lvl 2 South Block, Nepean Hospital
Cnr Derby and Somerset St
Kingswood NSW 2747
Country
Australia
Secondary sponsor category [1] 294453 0
None
Name [1] 294453 0
Address [1] 294453 0
Country [1] 294453 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296932 0
Nepean Blue Mountains Local Health DIstrict HREC
Ethics committee address [1] 296932 0
Ethics committee country [1] 296932 0
Australia
Date submitted for ethics approval [1] 296932 0
16/09/2016
Approval date [1] 296932 0
07/11/2016
Ethics approval number [1] 296932 0
HREC/16/NEPEAN/120

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72474 0
Dr Girish Deshpande
Address 72474 0
Neonatal Intensive Care Unit
Lvl 2 South Block, Nepean Hospital
Cnr Derby and Somerset St
Kingswood NSW 2747
Country 72474 0
Australia
Phone 72474 0
+61 (02) 4734 2121
Fax 72474 0
+61 (02) 4734 2698
Email 72474 0
girish.deshpande@health.nsw.gov.au
Contact person for public queries
Name 72475 0
Girish Deshpande
Address 72475 0
Neonatal Intensive Care Unit
Lvl 2 South Block, Nepean Hospital
Cnr Derby and Somerset St
Kingswood NSW 2747
Country 72475 0
Australia
Phone 72475 0
+61 (02) 4734 2121
Fax 72475 0
+61 (02) 4734 2698
Email 72475 0
girish.deshpande@health.nsw.gov.au
Contact person for scientific queries
Name 72476 0
Girish Deshpande
Address 72476 0
Neonatal Intensive Care Unit
Lvl 2 South Block, Nepean Hospital
Cnr Derby and Somerset St
Kingswood NSW 2747
Country 72476 0
Australia
Phone 72476 0
+61 (02) 4734 2121
Fax 72476 0
+61 (02) 4734 2698
Email 72476 0
girish.deshpande@health.nsw.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.