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

This study has been completed.
Sponsor:
Information provided by:
University of Oslo
ClinicalTrials.gov Identifier:
NCT00226187
First received: September 22, 2005
Last updated: February 14, 2007
Last verified: September 2005
History of Changes
  Purpose

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 Intervention
Infant, Low Birth Weight
 Procedure: Supplement of fatty acid (DHA and AA)

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • Cognitive development

Secondary Outcome Measures:
  • Growth
  • Adverse events

Estimated Enrollment: 140
Study Start Date: December 2003
  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226187

Locations
Norway
University of Oslo
Oslo, Norway, 0316
Sponsors and Collaborators
University of Oslo
Investigators
Study Chair: Christian A Drevon, Dr. Med. University og Oslo
  More Information

No publications provided by University of Oslo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00226187     History of Changes
Other Study ID Numbers: 1
Study First Received: September 22, 2005
Last Updated: February 14, 2007
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by University of Oslo:
Fatty acids
Human milk
Infant development
Very low birthweight infants

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013