The Brigance Assessment Of Individual Neurodevelopment In Young Children With Sickle Cell Disease- 2
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 248
- Locations
- 1
- Primary Endpoint
- Compare development in 3 year old children with SCD who are not on treatment to age matched controls using pass/fail rate for the Brigance Preschool Screen II.
Study Overview
Brief Summary
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.
Detailed Description
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:
- To compare the raw scores of the Brigance Preschool Screen II between SCD and control groups.
- 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.
- To compare the pass/fail rate and the raw scores between SCD patients on hydroxyurea treatment and the healthy controls
- To assess the influence of medical factors on the Brigance Preschool Screen II performance in children with SCD.
- To assess the influence of socioeconomic factors on the Brigance Preschool II results in children with SCD and controls.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 3 Years to 4 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Compare development in 3 year old children with SCD who are not on treatment to age matched controls using pass/fail rate for the Brigance Preschool Screen II.
Time Frame: 4 years
Secondary Outcomes
- Assess the influence of socioeconomic factors on the Brigance Preschool II results in children with SCD and controls.(4 years)
- Compare the raw scores of the Brigance Preschool Screen II between SCD and control groups.(4 years)
- Compare the pass/fail rate and the raw scores between SCD patients on hydroxyurea treatment and the healthy controls(4 years)
- Assess the influence of medical factors on the Brigance Preschool Screen II performance in children with SCD.(4 years)
- 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.(4 years)