- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00457990
Neurodevelopment After Early Iron Supplementation
Early Versus Late Enteral Iron Supplementation in Infants With a Birth Weight of Less Than 1301g - Neurocognitive Development at 5.3 Years Corrected Age
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.
Study Overview
Status
Intervention / Treatment
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 (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
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ulm, Germany, 89070
- University Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- inborn infants with a birth weight of <1301g admitted between June 1996 and June 1999
Exclusion Criteria:
- major anomalies, hemolytic disease, twin-to-twin transfusion syndrome, missing parental consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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ferritin at 61 days of life
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the number of infants who fulfilled the criteria of ID at any time throughout the study.
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Secondary Outcome Measures
Outcome Measure |
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Neurological Status
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Mental Processing Composite (Kaufmann Assessment Battery for Children)
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Disability Status
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Behavioural Problems
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Axel R Franz, MD, University of Ulm
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UL-NEO-IRON-2
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