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

Not Applicable

Completed

• Conditions: Infant, Low Birth Weight

• Registration Number: NCT00226187
• Lead Sponsor: University of Oslo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Status Verified: 2005-09
• Study First Submitted: 2005-09-22
• Study First Submitted QC: 2005-09-23
• Study First Posted: 2005-09-26
• Last Update Submitted: 2007-02-14
• Last Update Posted: 2007-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cognitive development

Secondary Outcome Measures

Name	Time	Method
Growth
Adverse events

Trial Locations

Locations (1)

University of Oslo; 🇳🇴 Oslo, Norway