Neurodevelopment After Early Iron Supplementation

This study has been completed.
Sponsor:
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT00457990
First received: April 6, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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 Intervention
Iron Deficiency
Anemia of Prematurity
Neurodevelopmental Delay
Drug: Oral administration of ferrous sulphate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by University of Ulm:

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

Secondary Outcome Measures:
  • Neurological Status
  • Mental Processing Composite (Kaufmann Assessment Battery for Children)
  • Disability Status
  • Behavioural Problems

Estimated Enrollment: 204
Study Start Date: April 2002
Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   4 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457990

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

No publications provided by University of Ulm

Additional 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
Study First Received: April 6, 2007
Last Updated: April 6, 2007
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Anemia
Anemia, Neonatal
Infant, Premature, Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Infant, Newborn, Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 22, 2014