A Randomized Clinical Trial on Supplementation of DHA and... | NCT00226187

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

NCT00226187

Sponsor

University of Oslo

Status

Completed

Last Update Posted

Feb 15, 2007Estimated

Enrollment

140

Phase

Not Applicable

Conditions

Infant, Low Birth Weight

Interventions

Supplement of fatty acid (DHA and AA)

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2003

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 22, 2005

First Submission Date that Met QC Criteria

Sep 23, 2005

First Posted Date

Sep 26, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2007

Last Update Posted Date

Feb 15, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140

Name	Type	Description	Arm Group Labels	Other Names
Supplement of fatty acid (DHA and AA)	Procedure

Measure	Description	Time Frame
Cognitive development

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

1 Month

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian A Drevon, Dr. Med.	University og Oslo	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Oslo		Oslo	Oslo	0316	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26939082	Derived	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.
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