Back to resultsNeurodevelopment After Early Iron Supplementation
Primary Purpose
Iron Deficiency, Anemia of Prematurity, Neurodevelopmental Delay
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Oral administration of ferrous sulphate
Sponsored by
About this trial
This is an interventional prevention trial for Iron Deficiency focused on measuring Neurocognitive outcome, preterm infant, very low birth weight, iron deficiency, iron supplementation
Eligibility 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
Sites / Locations
- University Children's Hospital
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00457990
Brief Title
Neurodevelopment After Early Iron Supplementation
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 Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Ulm
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency, Anemia of Prematurity, Neurodevelopmental Delay
Keywords
Neurocognitive outcome, preterm infant, very low birth weight, iron deficiency, iron supplementation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
204 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Oral administration of ferrous sulphate
Primary Outcome Measure Information:
Title
ferritin at 61 days of life
Title
the number of infants who fulfilled the criteria of ID at any time throughout the study.
Secondary Outcome Measure Information:
Title
Neurological Status
Title
Mental Processing Composite (Kaufmann Assessment Battery for Children)
Title
Disability Status
Title
Behavioural Problems
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel R Franz, MD
Organizational Affiliation
University of Ulm
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Children's Hospital
City
Ulm
ZIP/Postal Code
89070
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
17766527
Citation
Steinmacher J, Pohlandt F, Bode H, Sander S, Kron M, Franz AR. Randomized trial of early versus late enteral iron supplementation in infants with a birth weight of less than 1301 grams: neurocognitive development at 5.3 years' corrected age. Pediatrics. 2007 Sep;120(3):538-46. doi: 10.1542/peds.2007-0495.
Results Reference
derived
Learn more about this trial
Neurodevelopment After Early Iron Supplementation
We'll reach out to this number within 24 hrs