The project will aim to quantify very long-term sequelae after childhood BM (~31 years after infection) on a wide range of functional outcome domains: neurocognitive functioning, behavioral and emotional functioning, health related quality of life,…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters will be 1) neurocognitive outcome as measured by the Emma
Toolbox (an in-depth measure of neurocognitive functioning that was developed
in-house) and a short form of the Wechsler Adult Intelligence Scale IV
(WAIS-IV) estimating Full Scale IQ, 2) behavioral and emotional functioning as
measured by the Adult Self Report (ASR) and Post-traumatic Stress Disorder
Checklist for DSM-5 (PCL-5), 3) Health related quality of life as measured by
the Patient Reported Outcomes Measurement Information System (PROMIS) 29+2
Profile and the EuroQoL EQ-5D-5L, 4) Participation in society as measured by
the PROMIS Ability to Participate in Social Roles and Activities (PROMIS APS)
short form 8a and a custom participation questionnaire, and 5) hearing as
measured by the Amsterdam Inventory for Auditory Disability and Handicap
(AIADH).
Secondary outcome
Secondary study parameters will be brain structure and functioning (MRI
scanning)
Background summary
Bacterial meningitis (BM) is a life-threatening infection of the central
nervous system. The global burden of meningitis remains high in all age groups
and progress as a result of efforts to reduce this burden lags substantially
behind progress reached in other vaccine preventable diseases. In children, BM
can cause a wide range of sequelae that persist throughout childhood. The
long-term effects of childhood BM on functioning in adulthood remains largely
unknown. The importance of research into the effects of childhood BM in adult
age is evident, especially given that earlier findings have revealed that a
substantial proportion of survivors subjectively report impaired functional
outcome in early adult life. Additionally, the presence and type of
consequences of childhood BM can vary largely between children. Prediction of
protective and risk factors for very long-term sequelae would therefore be very
useful in clinical practice. In this regard, current prediction models are
insufficient due to the focus on mortality, lack of other relevant outcome
domains, relatively short follow-up period and/or use of conventional
statistical methods with limited flexibility to model complex relationships.
Study objective
The project will aim to quantify very long-term sequelae after childhood BM
(~31 years after infection) on a wide range of functional outcome domains:
neurocognitive functioning, behavioral and emotional functioning, health
related quality of life, participation in society, hearing, and brain structure
and function. Additionally, the project aims to investigate the neural
mechanisms underlying functional outcome, and to develop innovative prognostic
prediction models for very long-term outcome after childhood bacterial
meningitis.
Study design
This study is a prospective longitudinal observational follow-up.
Study burden and risks
For all participants, assessment includes: 1) Assessment of neurocognitive
functioning using the Emma Toolbox and a short form of the WAIS-IV. The Emma
Toolbox will be administered on a 15-inch laptop from a 50 cm viewing distance
and has a duration of 65 min. A short form of the WAIS-IV (consisting of the
subtests Vocabulary, Similarities, Matrix Rea-soning and Block Design) will be
used to estimate Full-scale IQ (FSIQ). Administration takes approximately 35
minutes. 2) Questionnaires assessing demographic and clinical characteristics
(custom general questionnaire), behavioral and emotional functioning (ASR,
PCL-5), health related quality of life (PROMIS 29+2 Profile, EQ-5D-5L),
participation in society (PROMIS APS short form 8a and a custom participation
questionnaire), and hearing (AIADH). Questionnaires will be administered
digitally for all participants. Time to complete all questionnaires is
estimated to be around 45 minutes. Additionally, a subsample of 64 survivors of
childhood meningitis (32 meningococcal meningitis survivors and 32 pneumococcal
meningitis survivors) and 64 controls will undergo the optional assessment of
brain structure and functioning using Magnetic Resonance Imaging (MRI) at the
on-campus Spinoza Centre for Neuroimaging. Estimated duration of MRI assessment
is 60 minutes.
Participants can complete all two or three assessments during one single
hospital visit. Based on planning restrictions or the participant*s preference,
a separate visit may be planned for the MRI scan. An additional 10 minutes will
be taken into account for the purpose of introducing participants to the study
and obtaining written informed consent. Altogether, total duration of the study
visit will be maximum 3.0 hours without MRI assessment, and maximum 4.0 hours
with MRI assessment.
Participation is associated with negligible risk, because no negative (side)
effects are known of the neuropsychological testing, questionnaires, and MRI
scanning used in the study. Financial burden due to travel and parking expenses
will be compensated, including costs for public transportation, at a rate of
¤0.23 per kilometer travelled. Additionally, participants receive a gift
voucher worth ¤25 for participation.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Childhood bacterial meningitis survivors:
1. History of childhood bacterial meningitis;
2. 18 years of age or older;
3. Fluent Dutch speaker.
Control group:
1. 21 years of age or older;
2. Fluent Dutch speaker;
3. No documented diagnosis of a neurological disorder (among which meningitis).
Exclusion criteria
1. Absence or withdrawal of written informed consent;
2. *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;
3. Somatic disorders unrelated to meningitis, congenital disorders, and severe
motor or sensory disabilities that interfere with outcome assessment at time of
assessment;
4. Inability to comprehend testing instructions at time of assessment.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85647.018.24 |