Trial registered on ANZCTR

Trial ID
Ethics application status
Date submitted
Date registered
Type of registration
Prospectively registered

Titles & IDs
Public title
The DINO Trial
Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format
Docosahexaenoic Acid (DHA) for the Improvement of Neurodevelopmental Outcome in Preterm Infants.
Secondary ID 32 0
Perinatal Trials Registry: PTR424
Universal Trial Number (UTN)
Trial acronym

Health condition
Health condition(s) or problem(s) studied:
Preterm Infants < or = 32 weeks 33 0
Condition category
Condition code
Reproductive Health and Childbirth 39 39 0 0
Childbirth and postnatal care

Study type
Description of intervention(s) / exposure
1. High - DHA feeding practice: mothers diet supplemented with tuna oil capsules 6x 500mg DHA rich tuna oil capsules per day to increase DHA in breast milk. If formula is required a high DHA commercial preterm formula is used.
The intervention will commence within 5 days of the preterm infant commencing enteral feeds and continue until the expected term date (40 weeks post menstrual age).
Follow up will occur at 4, 12 and 18 months corrected age.
Intervention code 1172 0
Other interventions
Comparator / control treatment
2. Standard infant feeding practice. Mothers take 6x500mg placebo soy oil capsules or standard preterm infant formula.
Control group

Primary outcome 68 0
Neurodevelopment assessed with the Bayleys Scales of Infant Development (II).
Timepoint 68 0
At 18 months corrected age
Primary outcome 288530 0
The primary outcome for the follow-up study at seven years' corrected age is general intellectual ability (Full Scale IQ) as estimated with the Wechsler Abbreviated Scale of Intelligence (WASI).
Timepoint 288530 0
Seven years' corrected age
Secondary outcome 123 0
Timepoint 123 0
Will be measured weekly from enrolment until estimated date of delivery (EDD) and then at 4, 12 and 18 months corrected age.
Secondary outcome 124 0
Timepoint 124 0
Markers of safety, such as episodes of necrotising enterocolitis and days to reach full enteral feeds will be collected and assessed.
Secondary outcome 300397 0
Secondary outcomes include cognitive function, educational progress, behaviour, quality of life, symptoms of asthma and allergy, anthropometrics and blood pressure.
Timepoint 300397 0
Seven years' corrected age

Key inclusion criteria
1. Infants born < or = 32 weeks gestation 2. Signed written informed consent 3. Family/guardians who speak English
Minimum age
Not stated
Maximum age
32 Weeks
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Infants with major congenital or chromosomal abnormalities 2. More than 5 days after commencing enteral feeds 3. Lactating mother with blood clotting disorder where tuna oil is contraindicated or regularly taking anticoagulant therapy 4. Participation in other clinical trials involving fatty acid intervention 5. Geographic location 6. Multiple births where not all live born infants are eligible.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centralised telephone randomisation service
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation schedule with balanced variable blocks, stratified by study site, gender and birthweight.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 3
Type of endpoint(s)

Anticipated date of first participant enrolment
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Target sample size
Actual sample size
Recruitment status
Closed: follow-up complete
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category 56 0
Government body
Name 56 0
National Health & Medical Research Council
Address 56 0
National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601
Country 56 0
Primary sponsor
Government body
Primary sponsor name
National Health and Medical Research Council
Primary sponsor address
GPO Box 1421 Canberra ACT 2601
Primary sponsor country
Secondary sponsor category 41 0
Name 41 0
Address 41 0
Country 41 0

Ethics approval
Ethics application status
Ethics committee name 361 0
Children Yout and Women's Health Service
Ethics committee address 361 0
Ethics committee country 361 0
Date submitted for ethics approval 361 0
Approval date 361 0
Ethics approval number 361 0
Ethics committee name 362 0
Flinders Medical Centre
Ethics committee address 362 0
Ethics committee country 362 0
Date submitted for ethics approval 362 0
Approval date 362 0
Ethics approval number 362 0
Ethics committee name 363 0
King Edward Memorial Hospital
Ethics committee address 363 0
Ethics committee country 363 0
Date submitted for ethics approval 363 0
Approval date 363 0
Ethics approval number 363 0
Ethics committee name 364 0
Royal Women's Hospital
Ethics committee address 364 0
Ethics committee country 364 0
Date submitted for ethics approval 364 0
Approval date 364 0
Ethics approval number 364 0
Ethics committee name 365 0
Royal Brisbane and Women's Hospita
Ethics committee address 365 0
Ethics committee country 365 0
Date submitted for ethics approval 365 0
Approval date 365 0
Ethics approval number 365 0

Brief summary
Docosahexaenoic Acid (DHA) is a long chain omega 3 polyunsaturated fatty acid which is important for growth and development. DHA also plays an essential role in the development of the central nervous system and retinal function in infants. Preterm infants are denied the large amount of DHA which is normally delivered via the placenta in the last trimester of pregnancy. The DINO trial is a multi-centre, randomized controlled trial to determine whether increasing the level of DHA in breast milk will improve the developmental outcome of preterm infants who are born less than 32 weeks gestation. Study participants, clinicians and trial personnel will be blinded to treatment allocation.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 35135 0
Prof Maria Makrides
Address 35135 0
Women's and Children's Health Research Institute
72 King William Road
North Adelaide SA 5006
Country 35135 0
Phone 35135 0
+61 8 8161 6179
Fax 35135 0
+61 8 8239 0267
Email 35135 0
Contact person for public queries
Name 10361 0
Dr Carmel Collins
Address 10361 0
Women's and Children's Health Research Institute
Flinders Medical Centre
Bedford Park SA 5042
Country 10361 0
Phone 10361 0
+61 8 8204 5575
Fax 10361 0
+61 8 8204 6296
Email 10361 0
Contact person for scientific queries
Name 1289 0
Dr Carmel Collins
Address 1289 0
Women's and Children's Health Research Institute
Flinders Medical Centre
Bedford Park SA 5042
Country 1289 0
Phone 1289 0
+61 8 8204 5575
Fax 1289 0
+61 8 8204 6296
Email 1289 0