NCT00998998

The Anemia Control Program: Early Intervention

Iron Deficiency Anemia and Infant Behavior: Early Intervention Study II

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 277 (actual)
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
• Sex: All
• Age: 6 Months – 12 Months
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Iron Deficiency Anemia

Interventions

Type	Name	Description
BEHAVIORAL	Home stimulation	Weekly visit of one hour to the home over the course of one year to foster the mother-child relationship.
BEHAVIORAL	Surveillance	Weekly visits to the home over the course of one year to record iron intake, feeding, and health information.
DIETARY_SUPPLEMENT	Iron	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.

Timeline

• Start date: 1992-04-01
• Primary completion: 1996-07-01
• Completion: 1996-07-01
• First posted: 2009-10-21
• Last updated: 2010-07-21

Locations

1 site across 1 country: Chile