Assessment of Cognitive Function, Fatigue and Health Related Quality of Life in Children With Beta Thalassemia

NCT05469230 | Completed DMC

• 1 other identifier: P.T.REC/012/003783
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to:

• Assess the cognitive function in children with beta thalassemia
• Evaluate the fatigue in beta thalassemic children
• Assess the health related quality of life measures in children with beta thalassemia.

Conditions

Cognitive Change; Beta-Thalassemia; Fatigue; Quality of Life

Outcome Measures

Primary Outcomes (3)

• assessing the change in cognitive function

  assessing the change in verbal comprehension, perceptual reasoning, processing speed, working memory and total IQ using Wecshler Intelligence Scale for Children (4th edition)

  baseline to 6 months

• Assessing the change in fatigue

  assessing the change in General Fatigue,Sleep/Rest Fatigue and Cognitive Fatigue using Pediatric quality of life inventory multidimensional fatigue scale (child report)

  Baseline to 6 months

• Assessing the change in health related quality of life

  assessing the change in physical, emotional, social and school functioning domains using the Pediatric quality of life inventory Generic core scale (child report) (version 4)

  Baseline to 6 months

Study Arms (2)

Typically developed children group

Typically developed children will be from both genders. the age range will be (8-16) years old and will be recruited from public governmental schools

Beta thalassemia group

children diagnosed with beta thalassemia major and intermedia will be recruited from Abo-El-Rish Pediatric Hospital. the age will be (8-16) years and will be from both genders

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

* Children diagnosed with beta thalassemia will be recruited from Abo El-Rish Pediatric Hospital .(Cairo University Hospitals) * Both genders will be included * Their age range from 8 to 16 years old shouldn't have any associated diseases with beta thalassemia

You may qualify if:

• Beta thalassemia group (Study group): Both genders will be included and their age range from 8 to 16 years old
• Typically developed children (control group):
• Healthy children will be recruited from public governmental schools
• Healthy controls, matching the patients in age, gender and educational level.
• It will be ensured from their past medical history and clinical examination that they and their first-degree relatives never had any chronic disease, including thalassemia.
• Both genders will be included
• Their age range from 8 to 16 years old

You may not qualify if:

• Beta thalassemia group (study group): Any child Suffering from any other chronic diseases other than thalassemia
• Having visual or auditory problems
• Typically developed children (control group):
• any child suffering from medical illness, musculoskeletal deformities, visual and auditory problems.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Abo El-Rish Pediatric Hospital

Giza, Egypt

Location

MeSH Terms

Conditions

beta-Thalassemia; Fatigue

Condition Hierarchy (Ancestors)

Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Esraa ibrahim, M.Sc

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 21, 2022
• Study Start: January 15, 2022
• Primary Completion: April 30, 2023
• Study Completion: May 30, 2023
• Last Updated: June 22, 2023

Record last verified: 2022-07

Locations

EG (1)