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Neurodevelopment After Early Iron Supplementation

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ClinicalTrials.gov Identifier: NCT00457990
Recruitment Status : Completed
First Posted : April 9, 2007
Last Update Posted : April 9, 2007
Information provided by:
University of Ulm

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.

Condition or disease Intervention/treatment
Iron Deficiency Anemia of Prematurity Neurodevelopmental Delay Drug: Oral administration of ferrous sulphate

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Prevention
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
Study Start Date : April 2002
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron
U.S. FDA Resources

Primary Outcome Measures :
  1. ferritin at 61 days of life
  2. the number of infants who fulfilled the criteria of ID at any time throughout the study.

Secondary Outcome Measures :
  1. Neurological Status
  2. Mental Processing Composite (Kaufmann Assessment Battery for Children)
  3. Disability Status
  4. Behavioural Problems

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00457990

University Children's Hospital
Ulm, Germany, 89070
Sponsors and Collaborators
University of Ulm
Principal Investigator: Axel R Franz, MD University of Ulm

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00457990     History of Changes
Other Study ID Numbers: UL-NEO-IRON-2
First Posted: April 9, 2007    Key Record Dates
Last Update Posted: April 9, 2007
Last Verified: April 2007

Keywords provided by University of Ulm:
Neurocognitive outcome
preterm infant
very low birth weight
iron deficiency
iron supplementation

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Trace Elements
Growth Substances
Physiological Effects of Drugs