No registrations found.
ID
Source
Brief title
Health condition
Children with Traumatic Brain Injury
Sponsors and support
Intervention
Outcome measures
Primary outcome
Motor functioning, neurocognitive functioning and behavioral functioning will be used to construct the overall outcome score
Secondary outcome
Brain structure and function, health status, school functioning, specific neurocognitive functioning, quality of life
Background summary
Outcome prediction in children with TBI falls short, preventing clinicians to tailor medical decision making to the child’s individual risk profile. This contributes to overtreatment (i.e. unnecessary follow-up) and undertreatment (i.e. undetected impairment). We aim to develop an innovative personalized prognostic model for outcome of children with TBI, using a unique combination of demographic, pre-injury and clinical predictors. The value of innovative MRI techniques and promising machine learning algorithms will be investigated for prognostic purposes that can be clinically implemented.
Study objective
To develop an innovative personalized prognostic model for outcome of pediatric TBI in crucial domains of child development (i.e. motor, neurocognitive, and, behavioral functioning), using a unique combination of demographic, pre-injury and clinical predictors. The prognostic model can importantly contribute to the planning of early rehabilitation and follow-up, preventing unnecessary care for children with good recovery and facilitating swift and adequate monitoring and treatment of children with high-risks of adverse outcome.
Study design
T0; hospital admission (demographic predictors, pre-injury predictors, clincial predictors)
T1; 1 month post-injury only for children aged 8 years and older (brain strucuture and function assessed with MRI)
T2; 6 months post-injury (motor, neurocognitive, and school functioning as well as brain function assessed with EEG)
Inclusion criteria
1. 4-18 years;
2. Fluent Dutch speaker;
3. Inhabitant of The Netherlands;
4. Hospital admission for mild to severe TBI.
5. No documented and/or parent-reported diagnosis of a neurological disorder (other than TBI).
Exclusion criteria
1. Absence or withdrawal of written informed consent;
2. Severe motor disability that interferes with outcome assessment at time of assessment;
3. Inability to comprehend testing instructions at time of assessment;
4. Somatic disorders unrelated to TBI and possibly affecting the outcome assessments at time of assessment.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9051 |
| CCMO | NL71283.018.19 |
| OMON | NL-OMON54521 |