Improving the Diagnostic Accuracy of Children with DoC (IDeAl DesiRE)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-25
SponsorIRCCS Eugenio Medea
About this trial
The present study aims to investigate the clinical evolution of children with severe ABI and DoC both by using the traditional behavioral scales, namely the CRS-R, CRS-P and CNCS, and by trying to establish whether it is possible to identify any clinical markers of Emergency (E-Markers). E-Markers are behaviors that indicate a content of consciousness irrespective of the processes investigated by behavioral scales, thus they could be combined with the items of these scales to improve the diagnosis.
A particular focus will be given to the identification of specific E-Markers for children aged less than 12 months, for which the CRS-P scale cannot be used. In this case, the E-markers will be compared with the specific developmental stages of newborns, giving great importance to motor abilities.
Eligibility criteria
Qualifiers
suffering from an ABI due to: traumatic brain injury, hypoxic events/anoxia, cerebral infections, cerebrovascular accident;
age: 2 months-25.11 years;
having a Glasgow Coma Scale (GCS; Teasdale & Jennett, 1974) at injury or onset ≤8);
being in vegetative state (VS) or minimally conscious state (MCS) at admission;
Disqualifiers
None
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Source ClinicalTrials.gov