Neurodevelopment After Early Iron Supplementation

Not Applicable

Completed

• Conditions: Iron Deficiency; Anemia of Prematurity; Neurodevelopmental Delay

• Registration Number: NCT00457990
• Lead Sponsor: University of Ulm

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.

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 Timeline

• Study Start: 2002-04
• Study Completion: 2005-12
• Status Verified: 2007-04
• Study First Submitted: 2007-04-06
• Study First Submitted QC: 2007-04-06
• Last Update Submitted: 2007-04-06
• Study First Posted: 2007-04-09
• Last Update Posted: 2007-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
the number of infants who fulfilled the criteria of ID at any time throughout the study.
ferritin at 61 days of life

Secondary Outcome Measures

Name	Time	Method
Disability Status
Behavioural Problems
Neurological Status
Mental Processing Composite (Kaufmann Assessment Battery for Children)

Trial Locations

Locations (1)

University Children's Hospital; 🇩🇪 Ulm, Germany