Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000382077
Ethics application status
Approved
Date submitted
1/04/2010
Date registered
12/05/2010
Date last updated
10/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Determining the docosahexaenoic acid dose to obtain plasma and erythrocyte phospholipid fatty acid profiles in preterm infants comparable to term infant profiles: a dose response pilot study.
Scientific title
In preterm infants born less than 33 weeks gestation will a tuna oil emulsion containing 121 mg/ml or 76 mg/ml of docosahexaenoic acid (DHA) compared with 37 mg/ml of DHA achieve an erythrocyte phospholipid fatty acid profile comparable to a term infant profile?
Secondary ID [1] 1595 0
None
Universal Trial Number (UTN)
Trial acronym
DINO-II pilot study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm infants 257083 0
Condition category
Condition code
Diet and Nutrition 257236 257236 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 257293 257293 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Infants are randomised to receive one of three solutions:
Aqueous emulsion of 19.5% DHA oil:
1) Containing 11.4 mg DHA. This will carry 121 mg of DHA for each ml of emulsion.
2) 66:33 blend of DHA and soy oil to give an emulsion that will carry 76 mg of DHA for each ml of emulsion.
3) Control (details in control field)
Administration for all three solutions: 1 ml/kg/day (given via feeding tube in 3 divided doses, 8 hourly) for 28 days.
Intervention code [1] 256250 0
Treatment: Other
Comparator / control treatment
Aqueous emulsion of 19.5% DHA oil:
33:66 blend of DHA and soy oil to give an emulsion that will carry 37 mg of DHA for each ml of emulsion.
Administration for all three solutions: 1 ml/kg/day (given via feeding tube in 3 divided doses, 8 hourly) for 28 days.
Control group
Dose comparison

Outcomes
Primary outcome [1] 258133 0
Blood (erythrocyte and plasma) phospholipid DHA levels analysed using gas chromotography.
Timepoint [1] 258133 0
Day 0, 7, 14, 21, 28
Secondary outcome [1] 263776 0
Tolerance of the enteral emulsions will be determined by comparing the number of days to reach full enteral feeds (>=150 mls/kg/day) and number of days in which one or more feeds were stopped.
Timepoint [1] 263776 0
Daily from study start to end (28 days)

Eligibility
Key inclusion criteria
Infants born less than 33 weeks gestation after one but before five days of commencing any enteral feeds and with parental/guardian consent. Multiple births will be eligible and will be randomised individually. Women providing breast milk for their infant not taking DHA supplements or willing to stop taking supplements for duration study.
Minimum age
2 Days
Maximum age
14 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants with major congenital or chromosomal abnormalities. Infants likely to be transferred to remote locations where weekly blood tests can’t be done.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The parent/s of eligible infants will be approached to enter the trial by the study neonatologist, or nominee; follow-up for consent will be by the study nurse. This will occur when the infant is nearing readiness to commence feeds. Upon consent, infants will be randomised to one of the three study emulsions and assigned a unique study ID. The Clinical Trials Pharmacist (who is not involved in study recruitment or conduct) holds the allocation schedule and assigns the study group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation schedule using variable block design was generated by statistician independent of study conduct. Stratification occurrred for sex, gestational age <28 weeks and 28 to 32 weeks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256752 0
Other
Name [1] 256752 0
Women's and Children's Health Research Institute
Country [1] 256752 0
Australia
Primary sponsor type
Other
Name
Women's and Children's Health Research Institute
Address
72 King William Road
North Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 256066 0
University
Name [1] 256066 0
The University of Adelaide
Address [1] 256066 0
Adelaide SA 5005
Country [1] 256066 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258764 0
Children, Youth and Women's Health Service
Ethics committee address [1] 258764 0
72 King William Road
North Adelaide SA 5006
Ethics committee country [1] 258764 0
Australia
Date submitted for ethics approval [1] 258764 0
Approval date [1] 258764 0
10/03/2010
Ethics approval number [1] 258764 0
REC2169/5/12

Summary
Brief summary
Infants born before 33 weeks are at high risk of developmental disorders and learning disabilities. We confirmed the importance of dietary docosahexaenoic acid (DHA) in preterm infants born <33 weeks gestation in a large, National Health and Medical Research Council funded (ID 250322), multi-centre randomised controlled trial (the DINO trial; ACTRN 12606000327583; JAMA. 2009;301:175-82). We demonstrated that DHA given at a dose designed to approximate the in utero accumulation rate (3 times the standard dietary dose) resulted in fewer preterm children with significant mental delay at 18 months corrected age compared with control. The effect of DHA-supplementation was most pronounced in girls born <33 weeks gestation and in infants born weighing <1250g.
Despite this some children (boys, infants born >1250g) failed to respond leading us to suspect that higher doses of DHA may be required. This was confirmed when we observed that the DHA level of preterm infants did not achieve levels seen in term infants. This was most likely caused by a number of factors: biological variability and compliance variation influenced the amount of DHA that appeared in breast milk, delay in reaching target infant milk volumes and losses due to oxidation for energy. A randomised controlled trial of higher-dose is warranted. Before undertaking such a trial a pilot study is needed to determine the effect of a higher DHA dose on plasma and erythrocyte phospholipid levels, and to assess the feasibility of giving DHA directly to the infant rather than as an addition to milk or formula.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31006 0
Address 31006 0
Country 31006 0
Phone 31006 0
Fax 31006 0
Email 31006 0
Contact person for public queries
Name 14253 0
Carmel Collins
Address 14253 0
Child Nutrition Research Centre
Flinders Medical Centre
Bedford Park SA 5042
Country 14253 0
Australia
Phone 14253 0
+61 8 8204 5755
Fax 14253 0
+61 8 8204 6296
Email 14253 0
[email protected]
Contact person for scientific queries
Name 5181 0
Carmel Collins
Address 5181 0
Child Nutrition Research Centre
Flinders Medical Centre
Bedford Park SA 5042
Country 5181 0
Australia
Phone 5181 0
+61 8 8204 5755
Fax 5181 0
+61 8 8204 6296
Email 5181 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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