Primary goal:To provide an overview of long term effects (neurocognitive, behavioral and learning problems) in children with MTHI and to identify specific risk groups with a higher prevalence of more serious problems. This knowledge can contribute…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Neurologisch/traumatisch hersenletsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This study targets long term effects (neurocognitive, behavioral and learning
problems) in children with MTHI. Disabilities in more or more of these domains
are the primary outcome which will be used to identify specific risk groups.
Secondary outcome
- Neurocognitive profile (disabilities in neurocognitive processes)
- Behavioral profile (reported by parents, teachers and the child itself)
- Learning problems (school results)
Background summary
Traumatic head injury (THI) is the most important cause of non congenital
disabilities in children. In Dutch hospitals on average we see 85.000 patients
each year with traumatic head injuries, of which 19.000 are pediatric patients.
Pediatric patients with THI have a higher risk of neurocognitive, behavioral
and learning problems. These problems can threaten the further development of
the young child.
Approximately 90% of all THIs is a mild traumatic head injury (MTHI). MTHI is
defined as trauma to the head, except for superficial trauma of the face. By
definition the trauma was caused by acceleration-deceleration trauma to the
head. To diagnose MTHI the following criteria were applied, 1) Glasgow Coma
Scale score of 13-15 at first examination at the emergency department, 2)
maximum duration of post traumatic loss of consciousness of 30 minutes, 3)
maximum duration of post traumatic amnesia of 24 hours.
Literature shows us that MTHI is followed by total recovery of initial symptoms
within several months. However, current literature is also characterized by a
high heterogeneity in outcomes in children with MTHI. Recent studies suggests
that specific risk groups exist that have a higher risk for permanent impact on
neurocognitive and behavioral functioning after MTHI. It is of great importance
to identify these high risk groups and to better predict their long term
outcomes. With that we can adjust the individual need of care of these children
and their families.
This study is a follow up study on a large multicenter prospective
observational cohort study of pediatric patients admitted to the emergency
department with a MTHI. Data of more than a thousand children were collected in
six community hospitals in The Netherlands between 1 April 2015 and 31 December
2016. The aim of this follow up study is to better predict long term effects
(neurocognitive, behavioral and learning problems) in children with MTHI. Our
goal is to identify specific high risk groups and thereby to better understand
how these problems can exist.
Study objective
Primary goal:
To provide an overview of long term effects (neurocognitive, behavioral and
learning problems) in children with MTHI and to identify specific risk groups
with a higher prevalence of more serious problems. This knowledge can
contribute to the accuracy of the prognosis in children with MTHI.
Secondary goal:
To understand the link between demographics, clinical predictors and long term
effects. Exploratory research will focus on the coherence in limitations in
different domains. Thereby, we can investigate in in what way specific
neurocognitive impairments can contribute to daily life problems.
This knowledge will contribute to the understanding of long term problems and
give way to targeted interventions.
Study design
This study is a observational follow up study on a large multicenter
prospective observational cohort study of pediatric patients admitted to the
emergency department with a MTHI. Data of more than a thousand children were
collected in six community hospitals in The Netherlands between 1 April 2015
and 31 December 2016.
We will contact all eligible parents and/or children by email. After a two
weeks notice we will contact them by phone. If eligible participants want to
participate we will arrange a test session in one of the community hospitals by
choice. During this 2 hour session the child will conduct a computerized and
standardized neurocognitive test under supervision of trained neuropsychology
students. Besides that we ask permission to retrieve school results and both
child and parents receive a standardized questionnaire on their functioning and
prehistory.
Data on demographics, traumamechanism, major and minor criteria according to
the current national guidelines, available radiography and clinical course
during possible observation, are already collected and categorized in an
electronic database (Research Manager). These data will be completed with
information on prehistory since trauma, neurocognitive testing, school results
and the questionnairet.
Study burden and risks
To our opinions there are no specific risks. Smaller previous studies show that
children are eager to do the neurocognitive tests and that they enjoy them.
Besides a two hour time investment we see no other burden.
Spaarnepoort 1
Hoofddorp 2134 TM
NL
Spaarnepoort 1
Hoofddorp 2134 TM
NL
Listed location countries
Age
Inclusion criteria
This is a follow up study from a cohort included between April 2015 and December 2016. All pediatric patients (aged 0-18 years) admitted to the emergency department with a mild traumatic head injury were eligible for inclusion. MTHI was defined as trauma to the head, except for superficial trauma of the face. By definition the trauma was caused by acceleration-deceleration trauma to the head. To diagnose MTHI the following criteria were applied, 1) Glasgow Coma Scale score of 13-15 at first examination at the emergency department, 2) maximum duration of post traumatic loss of consciousness of 30 minutes, 3) maximum duration of post traumatic amnesia of 24 hours.
A the time of follow up patients should be aged 6-18 years. During the initial inclusion at the emergency department their parents should have consented that we could approach them later for possible follow up studies.
Exclusion criteria
Children aged less than six years or 18 years and older.
Severe developmental delay.
Design
Recruitment
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 | NL65415.029.18 |