Trial from ANZCTR


Trial ID ACTRN12606000327583
Trial Status: Registered
Date Submitted: 27/03/2003
Date Registered: 27/03/2003
Prospectively registered

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Public title The DINO Trial
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Docosahexaenoic Acid (DHA) for the Improvement of Neurodevelopmental Outcome in Preterm Infants.
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Secondary ID [1] 32 0
Perinatal Trials Registry: PTR424
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UTN
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Trial acronym DINO
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Health condition(s) or problem(s) studied:
Preterm Infants < or = 32 weeks 33 0
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Condition category: Condition code:
Reproductive Health and Childbirth Childbirth and postnatal care
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Descriptions 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.
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Intervention Code:
Other interventions 1172 0
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Comparator / control treatment 2. Standard infant feeding practice. Mothers take 6x500mg placebo soy oil capsules or standard preterm infant formula.
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Control group Placebo
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Primary Outcome: Neurodevelopment assessed with the Bayleys Scales of Infant Development (II). 68 0
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Timepoint: At 18 months corrected age 68 0
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Primary Outcome: 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). 288530 0
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Timepoint: Seven years' corrected age 288530 0
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Secondary Outcome: Growth 123 0
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Timepoint: Will be measured weekly from enrolment until estimated date of delivery (EDD) and then at 4, 12 and 18 months corrected age. 123 0
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Secondary Outcome: Safety 124 0
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Timepoint: Markers of safety, such as episodes of necrotising enterocolitis and days to reach full enteral feeds will be collected and assessed. 124 0
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Secondary Outcome: Secondary outcomes include cognitive function, educational progress, behaviour, quality of life, symptoms of asthma and allergy, anthropometrics and blood pressure. 300397 0
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Timepoint: Seven years' corrected age 300397 0
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Key inclusion criteria 1. Infants born < or = 32 weeks gestation 2. Signed written informed consent 3. Family/guardians who speak English
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Minimum age Not stated
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Maximum age 32 Weeks
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Gender Both males and females
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Healthy volunteers? No
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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.
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Centralised telephone randomisation service
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Describe the 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.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Phase 3
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Anticipated date of first participant enrolment 23/12/2003
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 497
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Recruitment status Closed: follow-up complete
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Recruitment in Australia

Recruitment state(s) QLD,SA,WA,VIC
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Recruitment outside Australia

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Funding Source: Government body 56 0
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Name: National Health & Medical Research Council 56 0
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Address: National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601 56 0
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Country: Australia 56 0
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Primary Sponsor Government body
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Name: National Health and Medical Research Council
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Address: GPO Box 1421 Canberra ACT 2601
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Country: Australia
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Secondary Sponsor: None 41 0
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Name: Nil 41 0
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Address: 41 0
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Country: 41 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Children Yout and Women's Health Service 361 0
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Address: 361 0
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Country: Australia 361 0
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Approval Date: 09/05/2002 361 0
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Submitted Date: 361 0
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HREC: REC973/4/2005 361 0
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Ethics Committee name: Flinders Medical Centre 362 0
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Address: 362 0
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Country: Australia 362 0
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Approval Date: 09/05/2002 362 0
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Submitted Date: 362 0
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HREC: 122/023 362 0
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Ethics Committee name: King Edward Memorial Hospital 363 0
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Address: 363 0
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Country: Australia 363 0
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Approval Date: 30/05/2003 363 0
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Submitted Date: 363 0
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HREC: EC03-21.4 363 0
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Ethics Committee name: Royal Women's Hospital 364 0
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Address: 364 0
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Country: Australia 364 0
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Approval Date: 10/06/2003 364 0
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Submitted Date: 364 0
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HREC: 03/16 364 0
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Ethics Committee name: Royal Brisbane and Women's Hospita 365 0
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Address: 365 0
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Country: Australia 365 0
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Approval Date: 22/09/2003 365 0
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Submitted Date: 365 0
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HREC: RWH03/16 365 0
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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.
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
Title: Prof
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Name: Maria Makrides
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Address: Women's and Children's Health Research Institute 72 King William Road North Adelaide SA 5006
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Country: Australia
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Tel: +61 8 8161 6179
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Fax: +61 8 8239 0267
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Email: maria.makrides@health.sa.gov.au
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Contact person for public queries
Title: Dr
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Name: Carmel Collins
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Address: Women's and Children's Health Research Institute Flinders Medical Centre Bedford Park SA 5042
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Country: Australia
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Tel: +61 8 8204 5575
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Fax: +61 8 8204 6296
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Email: carmel.collins@health.sa.gov.au
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Contact person for scientific queries
Title: Dr
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Name: Carmel Collins
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Address: Women's and Children's Health Research Institute Flinders Medical Centre Bedford Park SA 5042
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Country: Australia
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Tel: +61 8 8204 5575
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Fax: +61 8 8204 6296
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Email: carmel.collins@health.sa.gov.au
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Contact person responsible for updating information
Title: Dr
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Name: Carmel Collins
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Address: Women's and Children's Health Research Institute Flinders Medical Centre Bedford Park SA 5042
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Country: Australia
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Tel: +61 8 8204 5575
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Fax: +61 8 8204 6296
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Email: carmel.collins@health.sa.gov.au
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Addition Cancer fields
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