Neurodevelopment After Early Iron Supplementation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Early Versus Late Enteral Iron Supplementation in Infants With a Birth Weight of Less Than 1301g - Neurocognitive Development at 5.3 Years Corrected Age

Conditions
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Iron Deficiency, Anemia of Prematurity, Neurodevelopmental Delay

Intervention / Treatment
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* Drug: Oral administration of ferrous sulphate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oral administration of ferrous sulphate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ferritin at 61 days of life |  |  | 
| the number of infants who fulfilled the criteria of ID at any time throughout the study. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological Status |  |  | 
| Mental Processing Composite (Kaufmann Assessment Battery for Children) |  |  | 
| Disability Status |  |  | 
| Behavioural Problems |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurocognitive outcome, preterm infant, very low birth weight, iron deficiency, iron supplementation