A Randomized Clinical Trial on Supplementation of DHA and AA to Preterm Infants

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00226187

Enrollment

140

Registered

2005-09-26

Start date

2003-12-31

Completion date

Unknown

Last updated

2007-02-15

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

Conditions

Infant, Low Birth Weight

Keywords

Fatty acids, Human milk, Infant development, Very low birthweight infants

Brief summary

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.

Interventions

PROCEDURESupplement of fatty acid (DHA and AA)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

No minimum to 1 Months

Healthy volunteers

Inclusion criteria

* Birth weight \< 1500 g * Born at one of 4 participating neonatal centers in Norway

Exclusion criteria

* Cerebral haemorrhage (stage 3 or 4) * Major congenital malformations that are supposed to affect growth and development * Illness that require prolonged parenteral nutrition (\>4 weeks)

Design outcomes

Primary

Measure	Time frame
Cognitive development	—

Secondary

Measure	Time frame
Growth	—
Adverse events	—

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026