Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00457990
Enrollment
204
Registered
2007-04-09
Start date
2002-04-30
Completion date
2005-12-31
Last updated
2007-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia of Prematurity, Iron Deficiency, Neurodevelopmental Delay

Keywords

Neurocognitive outcome, preterm infant, very low birth weight, iron deficiency, iron supplementation

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.

Interventions

Sponsors

University of Ulm
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
ferritin at 61 days of life
the number of infants who fulfilled the criteria of ID at any time throughout the study.

Secondary

MeasureTime frame
Neurological Status
Mental Processing Composite (Kaufmann Assessment Battery for Children)
Disability Status
Behavioural Problems

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026