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

Primary Purpose

Infant, Low Birth Weight

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Supplement of fatty acid (DHA and AA)

About this trial

This is an interventional treatment trial for Infant, Low Birth Weight focused on measuring Fatty acids, Human milk, Infant development, Very low birthweight infants

Eligibility Criteria

undefined - 1 Month (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University of Oslo

Outcomes

Primary Outcome Measures

Cognitive development

Secondary Outcome Measures

Growth

Adverse events

Full Information

NCT ID

NCT00226187

First Posted

September 22, 2005

Last Updated

February 14, 2007

Sponsor

University of Oslo

1. Study Identification

Unique Protocol Identification Number

NCT00226187

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Completed

Study Start Date

December 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Oslo

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infant, Low Birth Weight

Keywords

Fatty acids, Human milk, Infant development, Very low birthweight infants

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

140 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Supplement of fatty acid (DHA and AA)

Primary Outcome Measure Information:

Title

Cognitive development

Secondary Outcome Measure Information:

Title

Growth

Title

Adverse events

10. Eligibility

Sex

All

Maximum Age & Unit of Time

1 Month

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian A Drevon, Dr. Med.

Organizational Affiliation

University og Oslo

Official's Role

Study Chair

Facility Information:

Facility Name

University of Oslo

City

Oslo

ZIP/Postal Code

0316

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

26939082

Citation

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.

Results Reference

derived

PubMed Identifier

25986018

Citation

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.

Results Reference

derived

PubMed Identifier

18519483

Citation

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.

Results Reference

derived

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

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