Iron Supplementation of Marginally Low Birth Weight Infants

Phase 4

Completed

• Conditions: Anemia; Child Behavior Disorders; Iron-Deficiency; Cognitive Manifestations
• Interventions: Drug: Iron

• Registration Number: NCT00558454
• Lead Sponsor: Umeå University

Brief Summary

Iron is essential for brain development and there is a well established association between iron deficiency in infants and poor neurological development. In Sweden, about 5% of newborns have low birth weight (\< 2500 g). Due to small iron stores at birth and rapid postnatal growth, they have increased risk of iron deficiency and it is therefore important to prevent iron deficiency in this population. However, excessive iron supplementation can have adverse effects in infants such as growth impairment. In a randomized, controlled trial, we are investigating the effects of 0, 1 or 2 mg/kg/d of iron on brain myelination, cognitive development and growth in low birth weight infants.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2007-11-14
• Study First Submitted QC: 2007-11-14
• Study First Posted: 2007-11-15
• Primary Completion: 2008-06
• Study Completion: 2014-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

• Marginally low birth weight (2000-2500 g)
• Healthy at inclusion(6 weeks of age)
• No previous blood transfusion
• No previous iron supplementation

Exclusion Criteria

• Anemia at inclusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Iron	Placebo
2	Iron	1 mg/kg/day from age 6 weeks to 6 months
3	Iron	2 mg/kg/day from age 6 weeks to 6 months

Primary Outcome Measures

Name	Time	Method
Neurological developement	6 months, 3 years and 7 years	6 mo: Auditory brain stem response (central conduction time) 3 y: CBCL - Parental questionnaire assessing behavioral problems and WIPPSI - test of cognitive functions 7 y: SDQ, 5-15 and CBCL - Parental questionnaires assessing behavioral problems, TeAch - test of behavioral problems and WISC - test of cognitive functions.

Secondary Outcome Measures

Name	Time	Method
Growth, Iron status, and Morbidity	3 years and 7 years
Growth (weight, length, head circumference, knee-heel length), Morbidity and Iron status (Hemoglobin, ferritin etc)	6 months

Trial Locations

Locations (2)

Karolinska Hospital (including Danderyd Hospital); 🇸🇪 Stockholm, Sweden

Umeå University Hospital; 🇸🇪 Umeå, Sweden