The Brigance Assessment Of Individual Neurodevelopment In Young Children With Sickle Cell Disease- 2

NCT01123863 | Completed

• 1 other identifier: BRAIN2
• Study Type: observational
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

Neuro cognitive deficits;; Brigance pre-school screen;

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 who are not on any treatment and those who are being treated with hydroxyurea.

  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

• Assess the influence of socioeconomic factors on the Brigance Preschool II results in children with SCD and controls.

  4 years

Study Arms (2)

Patient Group

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

Other: Brigance Preschool Screen -II

control group

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

Other: Brigance Preschool Screen -II

Interventions

Brigance Preschool Screen -II OTHER

Three-year-old children with SCD who are followed at the St. Jude Children's Research Hospital Sickle Cell Center will be offered developmental screening with the Brigance Preschool Screen II during their regular clinic visits. Along with the screening test, socioeconomic data will be collected using a short questionnaire. Families will be asked to participate in this study by allowing us to collect their test results, medical information and socioeconomic data to compare with data collected from the control group. Parents who decline participation in this study will still be offered the Brigance Preschool Screen II as part of their child's clinical care.

Patient Group

Eligibility Criteria

• Age: 3 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The patient group will consist of 3 year-old-children with SCD who are followed at the St. Jude Children's Research Hospital Sickle Cell Center. The control group will consist of 3-year-old children attending day care in Memphis.

You may qualify if:

• \<4.0 years of age
• African-American
• Diagnosis of sickle cell disease (HbSS, HbSC, HbSβºthalassemia, HbSβ\^+thalassemia)
• Followed at St. Jude Children's Research Hospital Sickle Cell Center

You may not qualify if:

• Previous stroke
• Patients who are currently on a chronic transfusion program
• Known diagnosis associated with significant cognitive impairment (e.g. Down syndrome, mental retardation)
• Previously tested with Brigance Preschool Screen-II
• CONTROL GROUP
• \<4.0 years of age
• African-American
• Attendee of day-care in Memphis area
• Known diagnosis associated with significant cognitive impairment (e.g. stroke, Down syndrome, mental retardation)
• Known diagnosis sickle cell disease (HbSS, HbSC, HbSβºthalassemia, HbSβ\^+thalassemia)
• Previously tested with Brigance Preschool Screen-II

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jeremie Estepp, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2010
• First Posted: May 14, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 28, 2018

Record last verified: 2015-06

Locations

US (1)