Iron Supplementation of Marginally Low Birth Weight Infants

Study Overview
=================
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.

Official Title
-----------------
Randomized, Controlled Study of Iron Supplementation of Infants With Birth Weights 2000-2500 g

Conditions
-----------------
Anemia, Iron-Deficiency, Child Behavior Disorders, Cognitive Manifestations

Intervention / Treatment
-----------------
* Drug: Iron


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 39 Days
Maximum Age: 45 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: Iron<br>* Ferrous succinate mixture<br>* Other names: Ferromyn S, AstraZeneca, Södertälje, Sweden;|
| Experimental: 2<br>1 mg/kg/day from age 6 weeks to 6 months | Drug: Iron<br>* Ferrous succinate mixture<br>* Other names: Ferromyn S, AstraZeneca, Södertälje, Sweden;|
| Experimental: 3<br>2 mg/kg/day from age 6 weeks to 6 months | Drug: Iron<br>* Ferrous succinate mixture<br>* Other names: Ferromyn S, AstraZeneca, Södertälje, Sweden;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological developement | 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. | 6 months, 3 years and 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth (weight, length, head circumference, knee-heel length), Morbidity and Iron status (Hemoglobin, ferritin etc) |  | 6 months | 
| Growth, Iron status, and Morbidity |  | 3 years and 7 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iron supplements, Infant, Low birth weight, Prevention of iron deficiency and its physiological consequences, Safety