Neurodevelopment After Early Iron Supplementation
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.
Anemia of Prematurity
Drug: Oral administration of ferrous sulphate
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
|Official Title:||Early Versus Late Enteral Iron Supplementation in Infants With a Birth Weight of Less Than 1301g – Neurocognitive Development at 5.3 Years Corrected Age|
- ferritin at 61 days of life
- the number of infants who fulfilled the criteria of ID at any time throughout the study.
- Neurological Status
- Mental Processing Composite (Kaufmann Assessment Battery for Children)
- Disability Status
- Behavioural Problems
|Study Start Date:||April 2002|
|Study Completion Date:||December 2005|
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 (GMFCS>1), 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 (GMFCS=0), and normal cognitive development (MPC>85) and the absence of any severe hearing and visual impairment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457990
|University Children's Hospital|
|Ulm, Germany, 89070|
|Principal Investigator:||Axel R Franz, MD||University of Ulm|