Haemolytic Uraemic Syndrome in Childhood: Clinical, Cognitive and Psychological Aspects
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|ClinicalTrials.gov Identifier: NCT01666548|
Recruitment Status : Completed
First Posted : August 16, 2012
Last Update Posted : September 4, 2013
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.
|Condition or disease|
|Hemolytic-Uremic Syndrome Children Parents Psychological Adjustment|
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 Children`s 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 Type :||Observational|
|Actual Enrollment :||89 participants|
|Official Title:||Haemolytic Uraemic Syndrome in Childhood: Clinical, Cognitive and Psychological Aspects|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
- - renal function (estimated glomerular filtration rate according to the SCHWARTZ formula) after haemolytic uraemic syndrome in childhood [ Time Frame: 1 year 5 months ]
- - quality of life of children with haemolytic uraemic syndrome and their parents [ Time Frame: 1 year 5 months ]
- - neuropsychological sequelae of children with haemolytic uraemic syndrome [ Time Frame: 1 year 5 months ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666548
|Nephrology Unit of the University Children`s Hospital Zurich|
|Zurich, Switzerland, CH-8032|
|Principal Investigator:||Giuseppina Spartà, MD||Nephrology Unit, University Children`s Hospital, Zurich, Steinwiesstrasse 75, CH-8032 Zürich, Switzerland|