Determining the docosahexaenoic acid dose to obtain plasma and erythrocyte phospholipid fatty acid profiles in preterm infants comparable to term infant profiles: a dose response pilot study.

In preterm infants born less than 33 weeks gestation will a tuna oil emulsion containing 121 mg/ml or 76 mg/ml of docosahexaenoic acid (DHA) compared with 37 mg/ml of DHA achieve an erythrocyte phospholipid fatty acid profile comparable to a term infant profile?

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000382077

Acronym

DINO-II pilot study

Enrollment

Registered

2010-05-12

Start date

2010-05-20

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Infants born before 33 weeks are at high risk of developmental disorders and learning disabilities. We confirmed the importance of dietary docosahexaenoic acid (DHA) in preterm infants born <33 weeks gestation in a large, National Health and Medical Research Council funded (ID 250322), multi-centre randomised controlled trial (the DINO trial; ACTRN 12606000327583; JAMA. 2009;301:175-82). We demonstrated that DHA given at a dose designed to approximate the in utero accumulation rate (3 times the standard dietary dose) resulted in fewer preterm children with significant mental delay at 18 months corrected age compared with control. The effect of DHA-supplementation was most pronounced in girls born <33 weeks gestation and in infants born weighing <1250g. Despite this some children (boys, infants born >1250g) failed to respond leading us to suspect that higher doses of DHA may be required. This was confirmed when we observed that the DHA level of preterm infants did not achieve levels seen in term infants. This was most likely caused by a number of factors: biological variability and compliance variation influenced the amount of DHA that appeared in breast milk, delay in reaching target infant milk volumes and losses due to oxidation for energy. A randomised controlled trial of higher-dose is warranted. Before undertaking such a trial a pilot study is needed to determine the effect of a higher DHA dose on plasma and erythrocyte phospholipid levels, and to assess the feasibility of giving DHA directly to the infant rather than as an addition to milk or formula.

Interventions

Infants are randomised to receive one of three solutions: Aqueous emulsion of 19.5% DHA oil: 1) Containing 11.4 mg DHA. This will carry 121 mg of DHA for each ml of emulsion. 2) 66:33 blend of DHA and soy oil to give an emulsion that will carry 76 mg of DHA for each ml of emulsion. 3) Control (details in control field) Administration for all three solutions: 1 ml/kg/day (given via feeding tube in 3 divided doses, 8 hourly) for 28 days.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

2 Days to 14 Days

Healthy volunteers

Inclusion criteria

Infants born less than 33 weeks gestation after one but before five days of commencing any enteral feeds and with parental/guardian consent. Multiple births will be eligible and will be randomised individually. Women providing breast milk for their infant not taking DHA supplements or willing to stop taking supplements for duration study.

Exclusion criteria

Infants with major congenital or chromosomal abnormalities. Infants likely to be transferred to remote locations where weekly blood tests can’t be done.

Outcome results