Neurodevelopment After Early Iron Supplementation
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|ClinicalTrials.gov Identifier: NCT00457990|
Recruitment Status : Completed
First Posted : April 9, 2007
Last Update Posted : April 9, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Iron Deficiency Anemia of Prematurity Neurodevelopmental Delay||Drug: Oral administration of ferrous sulphate||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||204 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Study Start Date :||April 2002|
|Actual Study Completion Date :||December 2005|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00457990
|University Children's Hospital|
|Ulm, Germany, 89070|
|Principal Investigator:||Axel R Franz, MD||University of Ulm|