Haemolytic Uraemic Syndrome in Childhood: Clinical, Cognitive and Psychological Aspects
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | July 31, 2012 | ||||||||
| Last Updated Date | February 13, 2013 | ||||||||
| Start Date ICMJE | February 2012 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01666548 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Haemolytic Uraemic Syndrome in Childhood: Clinical, Cognitive and Psychological Aspects | ||||||||
| Official Title ICMJE | Haemolytic Uraemic Syndrome in Childhood: Clinical, Cognitive and Psychological Aspects | ||||||||
| 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. |
||||||||
| 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 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 ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: urine, native-blood, blood plasma, EDTA stabilized blood, heparin blood |
||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | children and youth from 2 months to 17 years in who had suffered from haemolytic uraemic syndrome |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 90 | ||||||||
| Estimated Completion Date | December 2016 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 2 Months to 17 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Switzerland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01666548 | ||||||||
| Other Study ID Numbers ICMJE | KEK-ZH-Nr. 2011-0394 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University Children's Hospital, Zurich | ||||||||
| Study Sponsor ICMJE | University Children's Hospital, Zurich | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | University Children's Hospital, Zurich | ||||||||
| Verification Date | February 2013 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||