Ignite Creation Date:
2024-05-06 @ 12:48 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01666548
Status:
COMPLETED
Last Update Posted:
2013-09-04
First Post:
2012-07-31
Brief Title:
Haemolytic Uraemic Syndrome in Childhood Clinical Cognitive and Psychological Aspects
Sponsor:
University Childrens Hospital Zurich
Organization:
University Childrens Hospital Zurich
Study Overview
Official Title:
Haemolytic Uraemic Syndrome in Childhood Clinical Cognitive and Psychological Aspects
Status:
COMPLETED
Status Verified Date:
2013-09
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:
The purpose of this study is to investigate the clinical cognitive outcome and psychosocial outcome of haemolytic uraemic syndrome in childhood
The haemolytic uraemic syndrome HUS is the leading cause of acute renal failure in childhood The more common typical HUS is mostly caused by Shigatoxin-producing enterohaemorrhagic Escherichia coli EHEC The rarer atypical HUS is mainly caused by different genetic abnormalities in complement regulatory proteins
About 50 till 60 percent of all patients with HUS develop a severe acute renal failure and require dialysis Resulting from new diagnostic and therapeutic approaches the survival rate increased during the last years Despite this there are only few data concerning long-term prognosis cognitive and motoric development as well as psychological coping and health-related quality of life of affected children and their parents
The haemolytic uraemic syndrome HUS is the leading cause of acute renal failure in childhood The more common typical HUS is mostly caused by Shigatoxin-producing enterohaemorrhagic Escherichia coli EHEC The rarer atypical HUS is mainly caused by different genetic abnormalities in complement regulatory proteins
About 50 till 60 percent of all patients with HUS develop a severe acute renal failure and require dialysis Resulting from new diagnostic and therapeutic approaches the survival rate increased during the last years Despite this there are only few data concerning long-term prognosis cognitive and motoric development as well as psychological coping and health-related quality of life of affected children and their parents
Detailed Description:
The main purposes of this study are the evaluation of the long-term renal function of pediatric HUS-patients the evaluation of the dialysis method in the acute phase of the disease and its impact on the duration of the renal-placement-therapy as well as the long-term renal function the evaluation of the intellectual and motoric performance of affected children and the evaluation of the health-related quality of life and psychological processing of the patients themselves and their parents
All cases of HUS treated at the University Childrens Hospital Zurich between 1995 and 2012 will be analyzed retrospectively In the course of a routine-follow-up-examination the clinical data of patients up to the age of 17 years will be actualized and completed The results of clinical and paraclinical investigations related to renal function will be evaluated to describe the clinical features of haemolytic uraemic syndrome in childhood
Intellectual performance will be analyzed with the Wechsler-Intelligence Scale for Children-IV WISC-IV and motoric performance with the Zurich Neuromotor Assessment in children at the age from 6 to 16 years
The health-related quality-of-life of all parents and affected children from the age of 7 years will be assessed by different generic quality-of-life-instruments
All cases of HUS treated at the University Childrens Hospital Zurich between 1995 and 2012 will be analyzed retrospectively In the course of a routine-follow-up-examination the clinical data of patients up to the age of 17 years will be actualized and completed The results of clinical and paraclinical investigations related to renal function will be evaluated to describe the clinical features of haemolytic uraemic syndrome in childhood
Intellectual performance will be analyzed with the Wechsler-Intelligence Scale for Children-IV WISC-IV and motoric performance with the Zurich Neuromotor Assessment in children at the age from 6 to 16 years
The health-related quality-of-life of all parents and affected children from the age of 7 years will be assessed by different generic quality-of-life-instruments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None