TY - JOUR
T1 - Towards PErsonalised PRognosis for children with traumatic brain injury
T2 - the PEPR study protocol
AU - Kooper, Cece C.
AU - Oosterlaan, Jaap
AU - Bruining, Hilgo
AU - Engelen, Marc
AU - Pouwels, Petra J. W.
AU - Popma, Arne
AU - van Woensel, Job B. M.
AU - Buis, Dennis R.
AU - Steenweg, Marjan E.
AU - Hunfeld, Maayke
AU - Königs, Marsh
N1 - Funding Information: This work was supported by the Amsterdam University Medical Centre (location AMC) through the Department of General Pediatrics. Subsidising parties were Cornelia Stichting (no award/grant number), Janivo Stichting (2017576), Dr CJ Vaillantfonds (no award/grant number) and Amsterdam Research & Development (V.000296). Publisher Copyright: © Author(s) (or their employer(s)) 2022.
PY - 2022/6/1
Y1 - 2022/6/1
N2 - INTRODUCTION: Traumatic brain injury (TBI) in children can be associated with poor outcome in crucial functional domains, including motor, neurocognitive and behavioural functioning. However, outcome varies between patients and is mediated by complex interplay between demographic factors, premorbid functioning and (sub)acute clinical characteristics. At present, methods to understand let alone predict outcome on the basis of these variables are lacking, which contributes to unnecessary follow-up as well as undetected impairments in children. Therefore, this study aims to develop prognostic models for the individual outcome of children with TBI in a range of important developmental domains. In addition, the potential added value of advanced neuroimaging data and the use of machine learning algorithms in the development of prognostic models will be assessed. METHODS AND ANALYSIS: 210 children aged 4-18 years diagnosed with mild-to-severe TBI will be prospectively recruited from a research network of Dutch hospitals. They will be matched 2:1 to a control group of neurologically healthy children (n=105). Predictors in the model will include demographic, premorbid and clinical measures prospectively registered from the TBI hospital admission onwards as well as MRI metrics assessed at 1 month post-injury. Outcome measures of the prognostic models are (1) motor functioning, (2) intelligence, (3) behavioural functioning and (4) school performance, all assessed at 6 months post-injury. ETHICS AND DISSEMINATION: Ethics has been obtained from the Medical Ethical Board of the Amsterdam UMC (location AMC). Findings of our multicentre prospective study will enable clinicians to identify TBI children at risk and aim towards a personalised prognosis. Lastly, findings will be submitted for publication in open access, international and peer-reviewed journals. TRIAL REGISTRATION NUMBER: NL71283.018.19 and NL9051.
AB - INTRODUCTION: Traumatic brain injury (TBI) in children can be associated with poor outcome in crucial functional domains, including motor, neurocognitive and behavioural functioning. However, outcome varies between patients and is mediated by complex interplay between demographic factors, premorbid functioning and (sub)acute clinical characteristics. At present, methods to understand let alone predict outcome on the basis of these variables are lacking, which contributes to unnecessary follow-up as well as undetected impairments in children. Therefore, this study aims to develop prognostic models for the individual outcome of children with TBI in a range of important developmental domains. In addition, the potential added value of advanced neuroimaging data and the use of machine learning algorithms in the development of prognostic models will be assessed. METHODS AND ANALYSIS: 210 children aged 4-18 years diagnosed with mild-to-severe TBI will be prospectively recruited from a research network of Dutch hospitals. They will be matched 2:1 to a control group of neurologically healthy children (n=105). Predictors in the model will include demographic, premorbid and clinical measures prospectively registered from the TBI hospital admission onwards as well as MRI metrics assessed at 1 month post-injury. Outcome measures of the prognostic models are (1) motor functioning, (2) intelligence, (3) behavioural functioning and (4) school performance, all assessed at 6 months post-injury. ETHICS AND DISSEMINATION: Ethics has been obtained from the Medical Ethical Board of the Amsterdam UMC (location AMC). Findings of our multicentre prospective study will enable clinicians to identify TBI children at risk and aim towards a personalised prognosis. Lastly, findings will be submitted for publication in open access, international and peer-reviewed journals. TRIAL REGISTRATION NUMBER: NL71283.018.19 and NL9051.
KW - Magnetic resonance imaging
KW - Paediatric intensive & critical care
KW - Paediatric neurology
KW - Paediatric neurosurgery
KW - Paediatric radiology
UR - http://www.scopus.com/inward/record.url?scp=85133144782&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/bmjopen-2021-058975
DO - https://doi.org/10.1136/bmjopen-2021-058975
M3 - Article
C2 - 35768114
SN - 2044-6055
VL - 12
SP - e058975
JO - BMJ Open
JF - BMJ Open
IS - 6
M1 - e058975
ER -