Neurodevelopment After Early Iron Supplementation

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457990
• Other study ID #: UL-NEO-IRON-2
• Status: Completed
• Phase: N/A
• First received: April 6, 2007
• Last updated: April 6, 2007
• Start date: April 2002
• Est. completion date: December 2005

Study information

• Verified date: April 2007
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 7 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia of Prematurity
• Anemia, Iron-Deficiency
• Anemia, Neonatal
• Infant, Premature, Diseases
• Iron Deficiency
• Neurodevelopmental Delay

Intervention

Drug:
• Oral administration of ferrous sulphate

Locations

Country	Name	City	State
Germany	University Children's Hospital	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ferritin at 61 days of life
Primary	the number of infants who fulfilled the criteria of ID at any time throughout the study.
Secondary	Neurological Status
Secondary	Mental Processing Composite (Kaufmann Assessment Battery for Children)
Secondary	Disability Status
Secondary	Behavioural Problems