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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00226187
First Posted: September 26, 2005
Last Update Posted: February 15, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Oslo
  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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00226187     History of Changes
Other Study ID Numbers: 1
First Submitted: September 22, 2005
First Posted: September 26, 2005
Last Update Posted: February 15, 2007
Last Verified: September 2005

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