Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226187
Status:
COMPLETED
Last Update Posted:
2007-02-15
First Post:
2005-09-22
Brief Title:
A Randomized Clinical Trial on Supplementation of DHA and AA to Preterm Infants
Sponsor:
University of Oslo
Organization:
University of Oslo
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 15 kg are randomized to either an intervention or a control group All infants receive fortified human milk and a daily dose of 05 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
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 15 kg are randomized to either an intervention or a control group All infants receive fortified human milk and a daily dose of 05 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None