A Randomized Clinical Trial on Supplementation of DHA and AA to Preterm Infants - Full Text View

Sponsored by:	University of Oslo
Information provided by:	University of Oslo
ClinicalTrials.gov Identifier:	NCT00226187

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)

MedlinePlus related topics: Dietary Supplements

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Publications indexed to this study:

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.

Study ID Numbers:	1
Study First Received:	September 22, 2005
Last Updated:	February 14, 2007
ClinicalTrials.gov Identifier:	NCT00226187
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by University of Oslo:

Fatty acids
Human milk
Infant development
Very low birthweight infants

Study placed in the following topic categories:

Body Weight
Birth Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on January 16, 2009