Docosahexaenoic Acid (DHA) for the Improvement of Neurodevelopmental Outcome in Preterm Infants -The DINO trial
South Australian Health and Medical Research Institute (SAHMRI)Dataset description
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.Identifiers
Source Study
Purpose
Treatment
Phase
Phase 3
Funding
Government body,National Health & Medical Research Council
Scientific enquiries
Dr Thomas Sullivan
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 wi .... Read more
Key Inclusion Criteria
1. Infants born < or = 32 weeks gestation 2. Signed written informed consent 3. Family/guardians who speak English
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.
Can healthy volunteers participate?
No
Population
Sample Size 657
Min. age 0 No limit
Max. age 32 Weeks
Sex Both males and females
Condition category Preterm Infants < or = 32 weeks
Condition code Reproductive Health and Childbirth
Intervention
Intervention code Other interventions
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.
Comparison
Control group Placebo
2. Standard infant feeding practice. Mothers take 6x500mg placebo soy oil capsules or standard preterm infant formula.
Outcomes
Outcome: Neurodevelopment assessed with the Bayleys Scales of Infant Development (II).Timepoint: At 18 months corrected age
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). Timepoint: Seven years' corrected age
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
De-identified, individual participant data (IPD) that underlie the results reported in the primary paper (text, tables, figures and appendices) will be available. Dataset(s) will be limited to those participants and variables that are necessary for completion of the approved research proposal
When will data be available?
Available after publication with no end date determined
Available to whom?
Data will be available to researchers who provide a methodologically sound research proposal following review and approval by the trial steering committee and completion of a signed data access agreement
Available for what types of analyses?
Data may be shared with researchers who provide a methodologically sound research proposal following review and approval by the trial steering committee and completion of a signed data access agreement