This study is part of a prospective cohort study in the University Medical Center Groningen aimed at the determination of prognostic factors for outcome of children with TBI. The study is a pilot study to determine the value of fNIRs for detection…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
traumatisch hersenletsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Evaluate the applicability of fNIRS measurements in children with TBI, obtained
in the acute phase after trauma and to verify its prognostic relevance for
outcome at 6 months.
Secondary outcome
Secondary objectives are to:
1) evaluate if cerebral hemodynamical changes in adolescents are related to
cognitive performance
2) evaluate the relation between cerebral hemodynamics in the acute phase and
clinical subtypes of TBI (history and genetically) in pediatric TBI;
Background summary
Traumatic brain injury (TBI) is one of the most important causes of morbidity
and mortality in children. In the Netherlands, annually 12000 children are seen
at the Emergency Department after sustaining a TBI. The application of most
cerebral imaging techniques in the pediatric population is hindered by several
disadvantages and side effects. The use of computed tomography (CT) should be
restricted, if possible, in the pediatric population because of the harmful
X-ray radiation exposure. With the use of functional Near Infrared Spectroscopy
(fNIRS) it is possible to obtain in a non-invasive manner information about
cerebral hemodynamics, without the disadvantages of X-ray exposure or motion
susceptibility. Furthermore, progressive edema in the acute phase might be
related to genetic profiles.
The primary objective of this study in children with TBI is to evaluate the
prognostic value of fNIRS values obtained in the acute phase of injury.
Combining this device with the simultaneous performance of cognitive tests in
the group of adolescents (10-18 years), will help to determine if there are
cognitive difficulties after TBI in relation with hemodynamical changes.
Study objective
This study is part of a prospective cohort study in the University Medical
Center Groningen aimed at the determination of prognostic factors for outcome
of children with TBI. The study is a pilot study to determine the value of
fNIRs for detection of hemodynamical changes in the acute phase after injury in
relation with outcome.
Study design
This study is part of a prospective cohort study in the University Medical
Center Groningen aimed at the determination of prognostic factors for outcome
of children with TBI. The study is a pilot study to determine the value of
fNIRs for detection of hemodynamical changes in the acute phase after injury in
relation with outcome as measured with the GOSE for children.
Study burden and risks
Measurements in this study do not have adverse consequences for those involved,
and there are no risks associated with participation. The time-consuming burden
will be acceptable as the duration of the fNIRS measurement for hemodynamical
evaluation takes 15 minutes. When patients have to perform an additional
cognitive test with the FNIRS assessment, the duration is 20 minutes per
session. In addition, questionnaires have to be filled out on three occasions
by the parents, i.e. during admission and at the outpatient department which is
part of care as usual.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
traumatic brain injury
GCS 3 -15
age 1 - 18 years
admittance to the ward
informed consent legal representive
Exclusion criteria
no follow-up
comorbidity
no comprehension of dutch language
psychiatric illness
earlier admission for tbi
limitations for fNIRS (anemia, hypercapnia, hypoxia)
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 | NL50825.042.14 |