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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (planned)
• Sponsor: University of Ulm · Academic / Other
• Sex: All
• Age: 4 Years – 7 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Iron Deficiency
• Anemia of Prematurity
• Neurodevelopmental Delay

Interventions

Type	Name	Description
DRUG	Oral administration of ferrous sulphate

Timeline

• Start date: 2002-04-01
• Completion: 2005-12-01
• First posted: 2007-04-09
• Last updated: 2007-04-09

Locations

1 site across 1 country: Germany