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ANZCTR Newsletter Issue 5, Dec 2009 National and multinational prospective trial registers - The Lancet commentary En route to international clinical trial transparency - The Lancet commentary Declaration of Helsinki now has trial registration requirement (paragraph 19) The 2007 National Health and Medical Research Council (NHMRC) revised National Statement on Ethical Conduct in Human Research includes clause regarding trial registration (page 36, section 3.3.12) The 2007 NHMRC Australian Code for the Responsible Conduct of Research includes a clause regarding trial registration (section 4.10). This Code applies to all NHMRC funded trials The National Ethics Application Form (NEAF) now includes a question regarding details of trial registration (Question 9.1.8.4) ICMJE expands scope of registration ANZCTR is one of the first Primary Registers in the WHO Register Network (Search Portal)
ANZCTR User Survey ANZCTR Statistics International Committee of Medical Journal Editors (ICMJE): June 2007 editorial International Committee of Medical Journal Editors (ICMJE): May 2005 editorial WHO International Clinical Trials Registry Platform (ICTRP) The World Health Organization announces new standards for registration of all human medical research WHO trial registration data set NHMRC Clinical Trials Centre National Health and Medical Research Council (NHMRC) information about the ANZCTR Frequently Asked Questions about the ANZCTR About the ANZCTR How to register a trial How to update a trial

Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 001427
ACTR Number: ACTRN12606000327583
Trial Status: Registered
Date Submitted: 27/03/2003
Date Registered: 27/03/2003

Page 1

Public title: The DINO Trial
ANZCTR registration title: Docosahexaenoic Acid (DHA) for the Improvement of Neurodevelopmental Outcome in Preterm Infants.
Secondary ID:Perinatal Trials Registry: PTR424 
UTN:
Trial acronym: DINO

Page 2

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

Page 3

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:Other interventions 
Comparator / control treatment: 2. Standard infant feeding practice. Mothers take 6x500mg placebo soy oil capsules or standard preterm infant formula.
Control group: Placebo

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Primary outcome:Neurodevelopment assessed with the Bayleys Scales of Infant Development (II). 
Timepoint:At 18 months corrected age 
Secondary outcome 1:Growth 
Timepoint:Will be measured weekly from enrolment until estimated date of delivery (EDD) and then at 4, 12 and 18 months corrected age. 
Secondary outcome 2:Safety 
Timepoint:Markers of safety, such as episodes of necrotising enterocolitis and days to reach full enteral feeds will be collected and assessed. 

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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
Minimum Age: Not stated
Maximum Age: 32 Weeks
Gender: Both males and females
Healthy volunteers? No
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.

Page 6
Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Randomised controlled trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): Centralised telephone randomisation service
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.
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
Assignment: Parallel
Other design features (specify):
Type of endpoint(s): Efficacy

Page 7
Phase Phase 3
Anticipated or actual start date: 23/12/2003
Target sample size: 497
Recruitment status: Closed: follow-up complete

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Funding source:Government funding body e.g. Australian Research Council 
Name:National Health & Medical Research Council 
Address:National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601 
Country:Australia 
Primary sponsor: Government funding body e.g. Department of Health
Name: National Health and Medical Research Council
Address: GPO Box 1421 Canberra ACT 2601
Country: Australia
Secondary sponsor:None 
Name:Nil 
Address: 
Country: 
Other collaborator: 

Page 9

Has the study received approval from at least one ethics committee? Yes
Ethics Committee name 1:Children Yout and Women's Health Service 
Address: 
Country:Australia 
Date of approval:9/05/2002 
HREC Number:REC973/4/2005 
Ethics Committee name 2:Flinders Medical Centre 
Address: 
Country:Australia 
Date of approval:30/05/2003 
HREC Number:122/023 
Ethics Committee name 3:King Edward Memorial Hospital 
Address: 
Country:Australia 
Date of approval:10/06/2003 
HREC Number:EC03-21.4 
Ethics Committee name 4:Royal Women's Hospital 
Address: 
Country:Australia 
Date of approval:22/09/2003 
HREC Number:03/16 
Ethics Committee name 5:Royal Brisbane and Women's Hospita 
Address: 
Country:Australia 
Date of approval:20/08/2003 
HREC Number:RWH03/16 
Countries of recruitment:Australia 
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:
Presentations / publication list:

Page 10

Contact person for public queries
Name: Karen Best
Address: Child Nutrition Research Centre 72 King William Street North Adelaide SA 5006
Country: Australia
Tel: +61 8 81616871
Fax: +61 8 81618228
Email: karen.best@cywhs.sa.gov.au

Contact person for scientific queries
Name: Maria Makrides
Address: Child Nutrition Research Centre 72 King William Street North Adelaide SA 5006
Country: Australia
Tel: +61 8 81616067
Fax: +61 8 81618228
Email: maria.makrides@cywhs.sa.gov.au

Contact person responsible for updating information
Name: Karen Best
Address: Child Nutrition Research Centre
72 King William Road
North Adelaide
Country: Australia
Tel: 0881616871
Fax: 0881618228
Email: karen.best@cywhs.sa.gov.au
   
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