The Brigance Assessment Of Individual Neurodevelopment In Young Children With Sickle Cell Disease- 2
- Conditions
- Sickle Cell Disease
- Interventions
- Other: Brigance Preschool Screen -II
- Registration Number
- NCT01123863
- Lead Sponsor
- St. Jude Children's Research Hospital
- 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:
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 248
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description control group Brigance Preschool Screen -II The control group will consist of 3-year-old children attending day care in the Memphis area and serve as a population that come from a similar socioeconomic background as the SCD patient population. Intervention: Brigance Preschool Screen -II Patient Group Brigance Preschool Screen -II This study will administer Brigance Preschool Screen -II to 3 year old children with SCD followed at St. Jude Children's Research Hospital Intervention: Brigance Preschool Screen -II
- Primary Outcome Measures
Name Time Method 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. 4 years
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States