Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06058260
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-16
First Post:
2023-09-13
Brief Title:
Assessment of Cognitive Function and Quality of Life in Thalassemic Children at Sohag University Hospital
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Assessment of Cognitive Function and Quality of Life in Thalassemic Children at Sohag University Hospital
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
Thalassemias are genetic diseases characterized by a deficit in the production of hemoglobin the protein contained in red blood cells that transports oxygen in the bloodstream The disease is qualified as α-thalassemia or β-thalassemia depending on whether the anomaly results from a defect in the synthesis of the alpha α chains or beta β chains making up the protein
It is the most prevalent chronic hemolytic anemia in Egypt 851 the carrier rate of thalassemia in 1000 normal subjects was found to be 9-102
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
The principles of treatment have been well defined which include a maintaining hemoglobin between 9 and 10 gdl by repeated packed cell transfusion b regular chelation therapy to maintain serum ferritin around 1000 ngdl c preventing the development of complications of the disease or secondary to therapy d ensuring normal growth and development This conventional treatment is required for life-long The main objective of thalassemia life-long treatment is to maintain good quality of life as close to near normal life there are many Factor that can affect 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
The assessment of HRQOL in children is essential for the provision of proper care since it helps in identifying the impact of the disease and treatment on children 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
Previous studies showed significantly different results between patients and controls regarding the intelligence quotient IQ
Thalassemias are genetic diseases characterized by a deficit in the production of hemoglobin the protein contained in red blood cells that transports oxygen in the bloodstream The disease is qualified as α-thalassemia or β-thalassemia depending on whether the anomaly results from a defect in the synthesis of the alpha α chains or beta β chains making up the protein
It is the most prevalent chronic hemolytic anemia in Egypt 851 the carrier rate of thalassemia in 1000 normal subjects was found to be 9-102
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
The principles of treatment have been well defined which include a maintaining hemoglobin between 9 and 10 gdl by repeated packed cell transfusion b regular chelation therapy to maintain serum ferritin around 1000 ngdl c preventing the development of complications of the disease or secondary to therapy d ensuring normal growth and development This conventional treatment is required for life-long The main objective of thalassemia life-long treatment is to maintain good quality of life as close to near normal life there are many Factor that can affect 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
The assessment of HRQOL in children is essential for the provision of proper care since it helps in identifying the impact of the disease and treatment on children 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
Previous studies showed significantly different results between patients and controls regarding the intelligence quotient IQ
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None