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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
Update:
Reason:
ANZCTR registration title:
Docosahexaenoic Acid (DHA) for the Improvement of Neurodevelopmental Outcome in Preterm Infants.
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Reason:
Secondary ID:
Perinatal Trials Registry: PTR424
UTN:
Update:
Reason:
Trial acronym:
DINO
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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.
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Reason:
Intervention code:
Other interventions
Comparator / control treatment:
2. Standard infant feeding practice. Mothers take 6x500mg placebo soy oil capsules or standard preterm infant formula.
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Reason:
Control group:
Placebo
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Reason:
Page 4
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.
Page 5
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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Reason:
Minimum Age:
Not stated
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Reason:
Maximum Age:
32
Weeks
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Reason:
Gender:
Both males and females
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Reason:
Healthy volunteers?
No
Update:
Reason:
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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Reason:
Page 6
Study type:
Interventional
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Reason:
Purpose of the study:
Treatment
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Allocation to intervention:
Randomised controlled trial
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Reason:
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
Centralised telephone randomisation service
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Reason:
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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Reason:
Masking / blinding:
Blinded (masking used)
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Reason:
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
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Reason:
Assignment:
Parallel
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Reason:
Other design features (specify):
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Type of endpoint(s):
Efficacy
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Reason:
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Page 7
Phase
Phase 3
Update:
Reason:
Anticipated or actual date of first participant enrolement:
23/12/2003
Update:
Reason:
Target sample size:
497
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Reason:
Recruitment status:
Closed: follow-up complete
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Reason:
Page 8
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
Update:
Reason:
Name:
National Health and Medical Research Council
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Reason:
Address:
GPO Box 1421 Canberra ACT 2601
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Reason:
Country:
Australia
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Secondary sponsor:
None
Name:
Nil
Address:
Country:
Other collaborator:
Page 9
Has the study received approval from at least one ethics committee?
Yes
Update:
Reason:
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.
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Reason:
Trial website:
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Presentations / publication list:
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Page 10
Contact person for public queries
Name:
Karen Best
Update:
Reason:
Address:
Child Nutrition Research Centre 72 King William Street North Adelaide SA 5006
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Reason:
Country:
Australia
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Reason:
Tel:
+61 8 81616871
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Reason:
Fax:
+61 8 81618228
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Reason:
Email:
karen.best@cywhs.sa.gov.au
Update:
Reason:
Contact person for scientific queries
Name:
Maria Makrides
Update:
Reason:
Address:
Child Nutrition Research Centre 72 King William Street North Adelaide SA 5006
Update:
Reason:
Country:
Australia
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Reason:
Tel:
+61 8 81616067
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Reason:
Fax:
+61 8 81618228
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Reason:
Email:
maria.makrides@cywhs.sa.gov.au
Update:
Reason:
Contact person responsible for updating information
Name:
Karen Best
Update:
Reason:
Address:
Child Nutrition Research Centre
72 King William Road
North Adelaide
Update:
Reason:
Country:
Australia
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Reason:
Tel:
0881616871
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Reason:
Fax:
0881618228
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Reason:
Email:
karen.best@cywhs.sa.gov.au
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