Skip to main content
OpenTrials
Completed

NCT Number: NCT00457990

Neurodevelopment After Early Iron Supplementation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Iron Deficiency Anemia Anemia of Prematurity Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Neurodevelopmental Delay Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Children's Hospital

Ulm, 89070, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral administration of ferrous sulphate

Drug

Primary outcomes

  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 outcomes

  1. Neurological Status

  2. Mental Processing Composite (Kaufmann Assessment Battery for Children)

  3. Disability Status

  4. Behavioural Problems

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2005
First posted
Apr 9, 2007
Registry last updated
Apr 9, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.