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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00457990
Other study ID # UL-NEO-IRON-2
Secondary ID
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
Est. primary completion date
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


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
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