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

Infant, Low Birth Weight Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00226187
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• First received: September 22, 2005
• Last updated: February 14, 2007
• Start date: December 2003

Study information

• Verified date: September 2005
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Month

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birth Weight
• Infant, Low Birth Weight

Intervention

Procedure:
• Supplement of fatty acid (DHA and AA)

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive development
Secondary	Growth
Secondary	Adverse events