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van CCT (UK)

van CCT (UK)

Long-term outcome of childhood bacterial meningitis

- candidate number28327
- NTR NumberNTR6891
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-dec-2017
- Secondary IDs2017.292 METC
- Public TitleLong-term outcome of childhood bacterial meningitis
- Scientific TitleThe Dutch 20|30 Postmeningitis study protocol: a cross-sectional follow-up study of a historical childhood meningitis cohort on long-term outcome
- hypothesisWe expect subtle sequelae such as cognitive impairment, academic- and/or behavioural disabilities and fine motor problems that occur 20% - 30% of the postmeningitic children to persist in adolescence and young adulthood
- Healt Condition(s) or Problem(s) studiedBacterial, Meningitis, Cognitive functioning, Social participation, Behavioural disorders, Quality of life
- Inclusion criteriaChildren were included at baseline when the causing pathogen of bacterial meningitis was Neisseria meningitides, Streptococcus pneumoniae, Streptococcus agalactiae, Escherichia coli or Listeria monocytogenes. Currently, the mean age of the first cohort will be 26 years (± 2.3 SD, range 22.0-31.0) and the mean age of the second cohort will be 19,7 years (± 1,89 SD, range 16.0-24.0)
- Exclusion criteriaChildren in the original cohorts were excluded when they were infected by Hib or other less common pathogens. Furthermore, children with ‘complex onset’ of meningitis (defined as: meningitis secondary to immunodeficiency states, central nervous system surgery, cranial trauma or cerebrospinal fluid shunt infections or relapsing meningitis) were excluded. Moreover, because the intention was to study the more subtle neuropsychological sequelae, children having cognitive or behavioural problems prior to meningitis, children or adolescents in whom severe cognitive disabilities (a ‘specialist’s diagnosis’ of mental retardation or pervasive developmental disorder) were diagnosed before or after meningitis were excluded and will be excluded in the present study.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-mrt-2018
- planned closingdate1-sep-2019
- Target number of participants379
- InterventionsThe participants are invited cross-sectionally and to complete the following online internet-based questionnaires:
- PROMIS Global Health 10
- PROMIS-29 Profile
- PROMIS Satisfaction 2.0
- Weiss Functional Impairment Rating Scale Self-Report
- Amsterdam Inventory for Auditory Disability and Handicap (AIADH)
- General Academic Achievement questions
- Behavior Rating Inventory of Executive Function- Adult Version (BRIEF-A)
- Adult Self Report
- iMTA Productivity Cost Questionnaire
- iMTA Medical Consumption Questionnaire

Patients who completed all questionnaires are approached approximately 6 months after commencement of the study to return a buccal swab for additional genetic analysis.
- Primary outcomeHealth-related quality of life (considered aberrant if PROMIS Global Health 10 and PROMIS-29 Profile scored < 50)
- Secondary outcome- Subjective hearing (divided in groups with severe hearing disability, moderate hearing disability and very little hearing disability)
- Executive functioning (clinically aberrant score >60)

- Behavioural and adaptive functioning (scores of ASR will be compared to norms, descriptive statistics will be performed on the Weiss functional impairment rating scale self-report)
- Economic self-sufficiency (based on scores of the iMTA productivity questionnaire)
- Medical care consumption (based on scores of the iMTA Medical Consumption Questionnaire)
- Academic achievement
- TimepointsWithin 18 months all questionnaires will be completed. Buccal swabs will be collected between six months after commencement and 18 months.
- Trial web site
- statusplanned
- CONTACT for SCIENTIFIC QUERIESProf. dr. A.M. Tutu-van Furth
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- Publicationsnone
- Brief summary Because bacterial meningitis is still a life-threatening infectious disease this study aims to provide more insight into the possible long-term sequelae which could have a significant impact on subsequent health state of childhood bacterial meningitis survivors. Prediction of outcome using host genetic risk factors and clinical variables may contribute to better understanding, timely intervention and thereby appropriate follow-up of children after bacterial meningitis.
- Main changes (audit trail)
- RECORD9-dec-2017 - 28-dec-2017

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