NCT00226187

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2005

Completed
Last Updated

February 15, 2007

Status Verified

September 1, 2005

First QC Date

September 22, 2005

Last Update Submit

February 14, 2007

Conditions

Infant, Low Birth Weight

Keywords

Fatty acidsHuman milkInfant developmentVery low birthweight infants

Outcome Measures

Primary Outcomes (1)

  • Cognitive development

Secondary Outcomes (2)

  • Growth

  • Adverse events

Interventions

Supplement of fatty acid (DHA and AA)PROCEDURE

Eligibility Criteria

AgeUp to 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Birth weight \< 1500 g
  • Born at one of 4 participating neonatal centers in Norway

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, Oslo County, 0316, Norway

Location

Related Publications (3)

  • Almaas AN, Tamnes CK, Nakstad B, Henriksen C, Grydeland H, Walhovd KB, Fjell AM, Iversen PO, Drevon CA. Diffusion tensor imaging and behavior in premature infants at 8 years of age, a randomized controlled trial with long-chain polyunsaturated fatty acids. Early Hum Dev. 2016 Apr;95:41-6. doi: 10.1016/j.earlhumdev.2016.01.021. Epub 2016 Mar 2.

    PMID: 26939082DERIVED

  • Almaas AN, Tamnes CK, Nakstad B, Henriksen C, Walhovd KB, Fjell AM, Due-Tonnessen P, Drevon CA, Iversen PO. Long-chain polyunsaturated fatty acids and cognition in VLBW infants at 8 years: an RCT. Pediatrics. 2015 Jun;135(6):972-80. doi: 10.1542/peds.2014-4094. Epub 2015 May 18.

    PMID: 25986018DERIVED

  • Henriksen C, Haugholt K, Lindgren M, Aurvag AK, Ronnestad A, Gronn 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. doi: 10.1542/peds.2007-1511.

    PMID: 18519483DERIVED

Study Officials

  • Christian A Drevon, Dr. Med.

    University og Oslo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 22, 2005

First Posted

September 26, 2005

Study Start

December 1, 2003

Last Updated

February 15, 2007

Record last verified: 2005-09

Locations

NO(1)