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OpenTrials
Completed

NCT Number: NCT00226187

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

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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Key information

Conditions

Infant, Low Birth Weight

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oslo

Oslo, 0316, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Supplement of fatty acid (DHA and AA)

Procedure

Primary outcomes

  1. Cognitive development

Secondary outcomes

  1. Growth

  2. Adverse events

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Registry information

Important dates

Study start
2003
First posted
Sep 26, 2005
Registry last updated
Feb 15, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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