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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

September 22, 2005
February 14, 2007
December 2003
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Cognitive development
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Complete list of historical versions of study NCT00226187 on ClinicalTrials.gov Archive Site
  • Growth
  • Adverse events
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A Randomized Clinical Trial on Supplementation of DHA and AA to Preterm Infants
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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.
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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Infant, Low Birth Weight
Procedure: Supplement of fatty acid (DHA and AA)
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Henriksen C, Haugholt K, Lindgren M, Aurvåg AK, Rønnestad A, Grønn M, Solberg R, Moen A, Nakstad B, Berge RK, Smith L, Iversen PO, Drevon CA. Improved cognitive development among preterm infants attributable to early supplementation of human milk with docosahexaenoic acid and arachidonic acid. Pediatrics. 2008 Jun;121(6):1137-45.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
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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)
Both
up to 1 Month
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00226187
1
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University of Oslo
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Study Chair: Christian A Drevon, Dr. Med. University og Oslo
University of Oslo
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP