A Randomized Clinical Trial on Supplementation of DHA and AA to Preterm Infants
|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.|
|ClinicalTrials.gov Identifier: NCT00226187|
Recruitment Status : Completed
First Posted : September 26, 2005
Last Update Posted : February 15, 2007
A randomized, double-blind trial of docosahexaenoic and arachidonic acid supplementation in breast-fed preterm infants
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.
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.
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|
|Infant, Low Birth Weight||Procedure: Supplement of fatty acid (DHA and AA)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||December 2003|
- Cognitive development
- Adverse events
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
|University of Oslo|
|Oslo, Norway, 0316|
|Study Chair:||Christian A Drevon, Dr. Med.||University og Oslo|