ConvulsionsNCT00456391
The Utility of Performing Brain CT Scan in Non Trauma Patients at the Pediatric Emergency Unit
An observational study of Convulsions and Increased Intracraneal Pressure, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Pediatric patients are admitted to the emergency room for diverse causes, beside trauma, patients can present with convulsions, suspicion of brain tumor or increased intracranial pressure. In most of the cases a brain CT is performed even before physical examination by a skilled neurologist. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Convulsions, Increased Intracraneal Pressure
- What is being tested?
- Medical history and Brain CT scan
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Oct 2006to Mar 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients in the pediatric age that underwent brain CT scan in the pediatric emergency room
Who cannot join
- Patients with recent history of trauma
Trial locations and contacts
1 site in 1 country.
Israel1 site
Pediatric Dpt B and Pediatric Emergency Room - HaEmek Medical Center
Afula, 18101
About this study
Official title: The Utility of Performing Brain CT Scan in Non Trauma Patients at the Pediatric Emergency Unit. A Retrospective Observational Study.
Pediatric patients are admitted to the emergency room for diverse causes, beside trauma, patients can present with convulsions, suspicion of brain tumor or increased intracranial pressure. In most of the cases a brain CT is performed even before physical examination by a skilled neurologist. The amount of radiation that the children are exposed is equivalent to 100 plain chest X rays. The purpose of this tudy is to examinate in a retrospective study what were the indications for CT study and what was the incidence of relevant abnormal findings that required emergency intervention or referral.
- Conditions
- Convulsions, Increased Intracraneal Pressure
- Being tested
- Medical history, Brain CT scan
- Keywords
- Brain CT scan, Pediatric emergency room
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical historyProcedure or surgery
Brain CT scanProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2007 (estimated)
- Study startOct 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConvulsionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Investigators
- Ariel Koren, MD, Study director, Pediatric Hematology Unit, Ha'Emek Medical CenterWaheeb Sakran, MD, Principal investigator, Pediatric Dpt B - Ha'Emek Medical CenterIzat Hatib, MD, Principal investigator, Pediatric Dpt B - Ha'Emek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456391
- Sponsor's protocol ID
- 5200906.EMC
- Status last verified
- Apr 2007
- First submitted
- 4 Apr 2007
- Last updated
- 5 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Performing Brain CT Scan in Non Trauma Patients at the Pediatric Emergency Unit. A Retrospective Observational Study.
- ClinicalTrials.gov ID
- NCT00456391
- Acronym / sponsor ID
- 5200906.EMC
- Conditions
- Convulsions, Increased Intracraneal Pressure
- Keywords
- Brain CT scan, Pediatric emergency room
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 5 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pediatric patients are admitted to the emergency room for diverse causes, beside trauma, patients can present with convulsions, suspicion of brain tumor or increased intracranial pressure. In most of the cases a brain CT is performed even before physical examination by a skilled neurologist. The amount of radiation that the children are exposed is equivalent to 100 plain chest X rays. The purpose of this tudy is to examinate in a retrospective study what were the indications for CT study and what was the incidence of relevant abnormal findings that required emergency intervention or referral.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All patients in the pediatric age that underwent brain CT scan in the pediatric emergency room
Key exclusion criteria (1 listed)
- Patients with recent history of trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical history | Procedure or surgery | – |
| Brain CT scan | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2007.
Related trials for Convulsions
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Stereotypical Prolonged Seizures
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Not yet recruitingPhase 4
Study of Electrocardiogram (ECG) Safety of Sezaby in Neonatal Seizures
Neonatal Seizure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariel Koren, MD study director
Pediatric Hematology Unit, Ha'Emek Medical Center
Waheeb Sakran, MD principal investigator
Pediatric Dpt B - Ha'Emek Medical Center
Izat Hatib, MD principal investigator
Pediatric Dpt B - Ha'Emek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Convulsions and Increased Intracraneal Pressure, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2007.