None listed
Conditions
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.
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.
Sponsors
National Health and Medical Research Council
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to 32 Weeks
Healthy volunteers
No
Inclusion criteria
1. Infants born < or = 32 weeks gestation 2. Signed written informed consent 3. Family/guardians who speak English
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.
Outcome results
None listed