Infant, Low Birth Weight Clinical Trial
A randomized, double-blind trial of docosahexaenoic and arachidonic acid supplementation in
breast-fed preterm infants
Background:
Docosahexaenoic acid (DHA) and arachidonic acid (AA) are essential for preterm infants.
Human milk and preterm formulas contain DHA and AA, but at lower concentrations than
required to approximate utero accretion rate.
Objective:
To evaluate the effect of a high dose DHA and AA supplement to breast-fed preterm infants in
the early neonatal period. Primary endpoints are neurodevelopment at 6 and 20 months of age.
Design:
A randomized double-blind placebo-controlled study is carried out in four Norwegian neonatal
centers.
Subjects and methods:
Infants with birth weight < 1.5 kg are randomized to either an intervention or a control
group. All infants receive fortified human milk, and a daily dose of 0.5 ml study oil per
100 ml milk. Infants in the intervention group receive oil with DHA and AA (Formulaid,
Martek, USA), while the control oil contains vegetable oil without DHA or AA. Blood samples
are collected at birth (cord), and at start and stop of the intervention. Plasma is analyzed
for fatty acid pattern using high performance liquid chromatography.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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