Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00457990
Status:
COMPLETED
Last Update Posted:
2007-04-09
First Post:
2007-04-06
Brief Title:
Neurodevelopment After Early Iron Supplementation
Sponsor:
University of Ulm
Organization:
University of Ulm
Study Overview
Official Title:
Early Versus Late Enteral Iron Supplementation in Infants With a Birth Weight of Less Than 1301g - Neurocognitive Development at 53 Years Corrected Age
Status:
COMPLETED
Status Verified Date:
2007-04
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:
Background Iron deficiency in early childhood may impair neurodevelopment
Aim To examine whether early iron supplementation improved neurodevelopment in preterm infants
Method Children who participated in a clinical trial of iron supplementation were invited for a neurodevelopmental follow-up examination at the time of school entry
Aim To examine whether early iron supplementation improved neurodevelopment in preterm infants
Method Children who participated in a clinical trial of iron supplementation were invited for a neurodevelopmental follow-up examination at the time of school entry
Detailed Description:
Children with a birth weight of 1301g who participated in a randomized controlled trial of early versus late enteral iron supplementation were evaluated applying a standardized neurological evaluation the Kaufmann Assessment Battery for Children and the Gross Motor Function Classification Scale GMFCS at the age of school entry
Severe disability was defined as any of the following any abnormal neurological examination associated with a severely impaired mobility GMFCS1 severe cognitive impairment mental processing composite MPC 51 hearing loss requiring amplification or blindness The absence of disability was defined as normal neurological examination normal mobility GMFCS0 and normal cognitive development MPC85 and the absence of any severe hearing and visual impairment
Severe disability was defined as any of the following any abnormal neurological examination associated with a severely impaired mobility GMFCS1 severe cognitive impairment mental processing composite MPC 51 hearing loss requiring amplification or blindness The absence of disability was defined as normal neurological examination normal mobility GMFCS0 and normal cognitive development MPC85 and the absence of any severe hearing and visual impairment
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