Haemolytic Uraemic Syndrome in Childhood: Clinical, Cognitive and Psychological Aspects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT01666548
First received: July 31, 2012
Last updated: September 3, 2013
Last verified: September 2013

July 31, 2012
September 3, 2013
February 2012
August 2013   (final data collection date for primary outcome measure)
  • - renal function (estimated glomerular filtration rate according to the SCHWARTZ formula) after haemolytic uraemic syndrome in childhood [ Time Frame: 1 year 5 months ] [ Designated as safety issue: No ]
  • - quality of life of children with haemolytic uraemic syndrome and their parents [ Time Frame: 1 year 5 months ] [ Designated as safety issue: No ]
  • - neuropsychological sequelae of children with haemolytic uraemic syndrome [ Time Frame: 1 year 5 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01666548 on ClinicalTrials.gov Archive Site
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Haemolytic Uraemic Syndrome in Childhood: Clinical, Cognitive and Psychological Aspects
Haemolytic Uraemic Syndrome in Childhood: Clinical, Cognitive and Psychological Aspects

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 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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples Without DNA
Description:

urine, native-blood, blood plasma, EDTA stabilized blood, heparin blood

Probability Sample

children and youth from 2 months to 17 years in who had suffered from haemolytic uraemic syndrome

  • Hemolytic-Uremic Syndrome
  • Children
  • Parents
  • Psychological Adjustment
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • children and youth from 2 months to 17 years who had suffered from haemolytic uraemic syndrome
  • willingness and ability to participate in the study
  • freely signed informed consent

Exclusion Criteria:

  • missing written informed consent
  • children who do not fulfil the age criterion
Both
2 Months to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01666548
KEK-ZH-Nr. 2011-0394
No
University Children's Hospital, Zurich
University Children's Hospital, Zurich
Not Provided
Principal Investigator: Giuseppina Spartà, MD Nephrology Unit, University Children`s Hospital, Zurich, Steinwiesstrasse 75, CH-8032 Zürich, Switzerland
University Children's Hospital, Zurich
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP