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

Sponsor
University of Oslo (Other)
Overall Status
Completed
CT.gov ID
NCT00226187
Collaborator
(none)
140
Enrollment
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Supplement of fatty acid (DHA and AA)
 N/A

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Study Start Date :
Dec 1, 2003

Outcome Measures

Primary Outcome Measures

  1. Cognitive development []

Secondary Outcome Measures

  1. Growth []

  2. Adverse events []

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 1 Month
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Oslo Oslo Norway 0316

Sponsors and Collaborators

  • University of Oslo

Investigators

  • Study Chair: Christian A Drevon, Dr. Med., University og Oslo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00226187
Other Study ID Numbers:
  • 1
First Posted:
Sep 26, 2005
Last Update Posted:
Feb 15, 2007
Last Verified:
Sep 1, 2005
Keywords provided by , ,
Fatty acids
Human milk
Infant development
Very low birthweight infants
Additional relevant MeSH terms:
Birth Weight

Study Results

No Results Posted as of Feb 15, 2007