Neurodevelopment After Early Iron Supplementation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2005-12-31

Brief Summary

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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

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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.

Conditions

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Iron Deficiency Anemia of Prematurity Neurodevelopmental Delay

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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Oral administration of ferrous sulphate

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Axel R Franz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Ulm

Locations

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University Children's Hospital

Ulm, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED

PMID: 17766527 (View on PubMed)

Other Identifiers

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UL-NEO-IRON-2

Identifier Type: -

Identifier Source: org_study_id