Iron Deficiency Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Prevention
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