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Completed

NCT Number: NCT01123863

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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

3 year–4 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

PATIENT GROUP

Inclusion criteria

  • 3.0-<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

Exclusion criteria

  • 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

Inclusion criteria

  • 3.0-<4.0 years of age
  • African-American
  • Attendee of day-care in Memphis area

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

    Time frame: 4 years

Secondary outcomes

  1. Compare the raw scores of the Brigance Preschool Screen II between SCD and control groups.

    Time frame: 4 years

  2. 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.

    Time frame: 4 years

  3. Compare the pass/fail rate and the raw scores between SCD patients on hydroxyurea treatment and the healthy controls

    Time frame: 4 years

  4. Assess the influence of medical factors on the Brigance Preschool Screen II performance in children with SCD.

    Time frame: 4 years

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

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
May 14, 2010
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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