ClinicalTrialsFinder
CompletedPhase 3ACTRN12606000327583

The DINO Trial

Docosahexaenoic Acid (DHA) for the Improvement of Neurodevelopmental Outcome in Preterm Infants.

Sponsor

National Health and Medical Research Council

Enrollment

640 participants

Start Date

Apr 4, 2001

Study Type

Interventional

Conditions

Preterm Infants < or = 32 weeks

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.

Eligibility

Sex: Both males and femalesMax Age: 32 Weekss

Inclusion Criteria1

  • Infants born < or = 32 weeks gestation 2. Signed written informed consent 3. Family/guardians who speak English

Exclusion Criteria1

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

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 commercia

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.

Locations(1)

QLD,SA,WA,VIC, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12606000327583