Sickle Cell Disease Clinical Trial
Official title:
The Brigance Assessment Of Individual Neurodevelopment In Young Children With Sickle Cell Disease- 2
A preliminary study was conducted involving 88 three-year-old children with sickle cell
disease (SCD) who were followed at the St. Jude Children's Research Hospital Sickle Cell
Center. They were offered developmental screening with the Brigance Preschool Screen-II test
during their regular clinic visits from January 2006 to August 2008. Data from this work
showed that 50% of 3 year old children with SCD had low developmental screening scores. In
addition, the low scores were found to be associated with less parental education and with
speech deficits. However they were not associated with sickle cell genotype and hemoglobin
level.
The primary goal of this study is to prospectively administer Brigance Preschool Screen -II
to 3 year old children with SCD and 3 year old children without SCD who come from similar
socioeconomic backgrounds and compare the results between the two groups.
The primary objective of this study is to compare development in 3 year old children with SCD
who are not on any treatment to age matched healthy controls using pass/fail rate for the
Brigance Preschool Screen II.
Secondary objectives:
1. To compare the raw scores of the Brigance Preschool Screen II between SCD and control
groups.
2. To compare the pass/fail rate and the raw scores between SCD patients who are not on any
treatment and those who are being treated with hydroxyurea.
3. To compare the pass/fail rate and the raw scores between SCD patients on hydroxyurea
treatment and the healthy controls
4. To assess the influence of medical factors on the Brigance Preschool Screen II
performance in children with SCD.
5. To assess the influence of socioeconomic factors on the Brigance Preschool II results in
children with SCD and controls.
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