The Anemia Control Program: Early Intervention

Study Overview
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Brief Summary
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The purpose of this study was to determine if a home-based intervention to foster child development improved behavior and development in infants with IDA.

Detailed Description
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Iron-deficiency anemia (IDA) is associated with alterations in infant behavior and development that may not correct with iron therapy. The purpose of this study was to determine if a home-based intervention to foster child development improved behavior and development in infants with IDA. IDA and non-anemic infants were randomly assigned to a year of intervention or surveillance only. Infants were enrolled and began study participation at 6 or 12 months. All infants were treated with oral iron and visited weekly to record iron intake, feeding, and health (surveillance). For infants randomized to intervention, the weekly home visit included an hour-long program fostering child development by supporting the mother-infant relationship. Psychologists, unaware of iron status or intervention assignment, assessed cognitive, motor, and social-emotional development (Bayley Scales) at the beginning, midpoint, and end of the year.

Official Title
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Iron Deficiency Anemia and Infant Behavior: Early Intervention Study II

Conditions
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Iron Deficiency Anemia

Intervention / Treatment
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* Behavioral: Home stimulation
* Behavioral: Surveillance
* Dietary Supplement: Iron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: birth weight >= 3.0kg singleton full-term birth routine vaginal delivery no major congenital anomalies no major perinatal complications no photo therapy no hospitalization for longer than 5 days no chronic illness no iron therapy from 1991-94, infants on >= 250 ml/day cow milk or formula from 1994-96, infants could be on < 250 ml/day cow milk or formula infants identified as anemic at 6 or 12 months and randomly selected nonanemic infants at 6 and 12 months Exclusion Criteria: residence outside 4 contiguous working-class communities on outskirts of Santiago, Chile another infant <12 months in household infant in child care illiterate or psychotic caregiver or no stable caregiver available to accompany the child for appointments. until mid-1994, exclusive breastfeeding, defined as >250 mL/d cow milk or formula

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>6 or 12 month old infants with iron deficiency anemia assigned to receive home stimulation program via weekly home visits over 1 year | Behavioral: Home stimulation<br>* Weekly visit of one hour to the home over the course of one year to foster the mother-child relationship.<br>Dietary Supplement: Iron<br>* Six-month-old infants treated orally for 1 y with 15 mg elemental Fe/d as ferrous sulfate. Twelve-month old infants treated orally for a minimum of 6 months with 30 mg elemental Fe/d.<br>|
| Active Comparator: 2<br>6 or 12 month old infants with iron deficiency anemia assigned to surveillance (weekly visits to monitor health and iron supplement) over 1 year | Behavioral: Surveillance<br>* Weekly visits to the home over the course of one year to record iron intake, feeding, and health information.<br>Dietary Supplement: Iron<br>* Six-month-old infants treated orally for 1 y with 15 mg elemental Fe/d as ferrous sulfate. Twelve-month old infants treated orally for a minimum of 6 months with 30 mg elemental Fe/d.<br>|
| Experimental: 3<br>Nonanemic infants identified at 6 or 12 months assigned to receive home stimulation program via weekly home visits over 1 year | Behavioral: Home stimulation<br>* Weekly visit of one hour to the home over the course of one year to foster the mother-child relationship.<br>Dietary Supplement: Iron<br>* Six-month-old infants treated orally for 1 y with 15 mg elemental Fe/d as ferrous sulfate. Twelve-month old infants treated orally for a minimum of 6 months with 30 mg elemental Fe/d.<br>|
| Active Comparator: 4<br>Nonanemic infants identified at 6 and 12 months assigned to surveillance (weekly visits to monitor health) over 1 year | Behavioral: Surveillance<br>* Weekly visits to the home over the course of one year to record iron intake, feeding, and health information.<br>Dietary Supplement: Iron<br>* Six-month-old infants treated orally for 1 y with 15 mg elemental Fe/d as ferrous sulfate. Twelve-month old infants treated orally for a minimum of 6 months with 30 mg elemental Fe/d.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant behavior and development |  | 6, 12, and 18 months; or 12, 18, and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron-deficiency anemia |  | 6, 12, and 18 months; or 12, 18 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iron deficiency anemia, infant behavior, infant development