Thalassemia Clinical Trial
Official title:
Assessment of Cognitive Function and Quality of Life in Thalassemic Children at Sohag University Hospital
Thalassemia syndromes are a heterogeneous group of single gene disorders, inherited in an autosomal recessive manner ,prevalent among all ethnic groups and in almost every country around the world . Once a child has been diagnosed as thalassemia, he has to take lifelong treatment , where cure is not attainable and treatment may be prolonged . It is a life-threatening and life-limiting condition that affects the patient clinically and psychologically, so Health-related Quality of Life (HRQOL) is likely to be an essential outcome for these patients. Quality of life in thalassemic children such as : Repeated visits to hospitals for regular blood transfusion, cost of chelation therapy, repeated laboratory tests for monitoring therapy and for early detection of any complications. also life-long costly therapy along with poor quality of life will have adverse impact on the family. A better understanding of the factors associated with HRQOL among children with thalassemia could have a direct effect on the development of more suitable clinical, counselling and social support programs to enhance treatment outcomes. Cognitive dysfunction was Reported either due to the disease or its treatment ,frequent school absences, frequent hospitalizations, and physical and social restrictions lead to cognitive dysfunction . This neurological involvement in thalassemic children is primarily silent, with subclinical manifestations that can only be detected by cognitive assessment tests.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | October 20, 2024 |
Est. primary completion date | October 20, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 18 Years |
Eligibility | Inclusion Criteria: - All the diagnosed thalassemic children age between 4 and 18 years. Exclusion Criteria: - Any other hematological disease. - Age less than 4 years and more than 18 years. |
Country | Name | City | State |
---|---|---|---|
Egypt | Sohag university Hospital | Sohag |
Lead Sponsor | Collaborator |
---|---|
Sohag University |
Egypt,
Choudhry VP. Thalassemia Minor and Major: Current Management. Indian J Pediatr. 2017 Aug;84(8):607-611. doi: 10.1007/s12098-017-2325-1. Epub 2017 Apr 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Stanford-Binet Intelligence Scale fifth edition | Assessment of Cognitive Function Minimum Value is 40 Maximum value is 160 Higher scores mean a better outcome | 12 months | |
Primary | Pediatric Quality of Life Inventory | Assessment of Quality of Life Minimum value is 0 Maximum value is 100 Higher scores mean a better outcome | 12 months |
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