Impaired ConsciousnessNCT03618745
Outcome Predictors of Non Traumatic Coma in Children
An observational study of Impaired Consciousness, run by Assiut University.
Trial summary
To catch the high risk comatosed child to improve service and direct the limited resources to those children in countries with limited resources . Read more about this study
- Who is it for?
- Ages 2 months to 18 years
- Conditions the study is for
- Impaired Consciousness
- What is being tested?
- CT brain
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 1 Dec 2019
- 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 2 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children admitted in Assiut University Hospital with impaired consciousness .
Who may be able to join
- disturbed conscious level
- Children's family signed consent of approval to participate in the study
Who cannot join
- Children aged <2 months or >18 years.
- Coma of traumatic etiology.
- Coma as part of an anticipated terminal illness.
Trial locations and contacts
No sites are listed yet.
Gamal Askar, prof contact
About this study
To catch the high risk comatosed child to improve service and direct the limited resources to those children in countries with limited resources .
Read the detailed description
Non Traumatic Coma in children is an important pediatric emergency. It has been an enigma for clinicians for many years. To find the cause of coma and to determine the prognosis is a taxing question for the attending clinicians and the primary concern for relatives in every case.
Non-traumatic coma in childhood accounts for high morbidity and mortality in pediatric age group. It can result from wide range of primary etiologies. Etiology of coma and clinical status at the time of admission are likely outcome predictors. Infection is the commonest etiology for coma in all age groups .
Coma in children is recognized to be a non-specific sign with a wide potential differential diagnosis. Among various etiological factors identified for non-traumatic coma, considerable regional diversity exists in them with infectious problems suggested to be more common in developing countries. There has been few case series in developing countries with specific reference to infective etiology and there are also differences in infective agents between developing and developed countries. Similarly prediction of outcome of coma is difficult early in the course of the illness, especially in children. There have been many studies suggesting prognostic parameters of coma in adults, but limited reviews are available for children.
Etiologically it can be divided into two broad categories: those without focal neurologic signs (e.g., metabolic encephalopathies); meningitis syndromes, characterized by fever or stiff neck and an excess of cells in the spinal fluid (e.g., bacterial meningitis, subarachnoid hemorrhage); and conditions associated with prominent focal signs (e.g., stroke, cerebral hemorrhage). In most instances coma is part of an obvious medical problem such as drug ingestion, hypoxia, stroke, trauma, or liver or kidney failure. Conditions that cause sudden coma include drug ingestion, cerebral hemorrhage, trauma, cardiac arrest, epilepsy, or basilar artery embolism. Coma that appears subacutely is usually related to a preceding medical or neurologic problem, including the secondary brain swelling of a mass lesion such as tumor or cerebral infarction.
Central nervous infections are the most common cause . Toxic-metabolic, status-epilepticus, hypoxic-ischemic, intracranial bleed etc. are other main causes.
Neurological outcome is often the foremost concern of parents and physicians .Etiology of coma and clinical status at the time of presentation are the most likely predictors of outcome. Simple clinical signs have been found as good predictors of outcome .
Non-traumatic coma is an important source of morbidity and mortality in the pediatric age group. Accurate diagnosis of etiology of childhood coma in resource poor countries is complicated by overlap in clinical presentation, limited diagnostic resources, disease endemicity and co-morbidity . Considerable skill is required to distinguish the group at high risk for further deterioration, potentially leading either to death or severe handicap. This study attempts to identify the common etiological factors of pediatric comatose patients as well as the predictors of poor outcomes in these patients .
Episodes were defined on the basis of a Glasgow Coma Score (GCS) of less than 12 for more than six hours . Many acutely ill children are not fully conscious because pathologic processes may affect the parts of the central nervous system that mediate consciousness; alteration in the state of consciousness is a common feature of many different conditions.
Many of these children make a full neurological recovery. However, depending on the underlying etiology non-traumatic coma may cause considerable mortality and morbidity in pediatric age group .
- Conditions
- Impaired Consciousness
- Being tested
- CT brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT brainDevice
noninvasive medical examination or procedure that uses specialized X-ray equipment to produce cross-sectional images of the body.
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of recovery from coma
clinical evaluation of the recovery symptoms and signs
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired ConsciousnessStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Zaka Saied, Assiut University
- Investigators
- Hanan Zaka, Principal investigator, World Health Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618745
- Sponsor's protocol ID
- Non Traumatic Coma in Children
- Status last verified
- Aug 2018
- First submitted
- 20 Jul 2018
- Last updated
- 7 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Predictors of Non Traumatic Coma in Children
- ClinicalTrials.gov ID
- NCT03618745
- Acronym / sponsor ID
- Non Traumatic Coma in Children
- Conditions
- Impaired Consciousness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 7 Aug 2018 (actual)
- 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.
To catch the high risk comatosed child to improve service and direct the limited resources to those children in countries with limited resources .
Detailed description
Non Traumatic Coma in children is an important pediatric emergency. It has been an enigma for clinicians for many years. To find the cause of coma and to determine the prognosis is a taxing question for the attending clinicians and the primary concern for relatives in every case.
Non-traumatic coma in childhood accounts for high morbidity and mortality in pediatric age group. It can result from wide range of primary etiologies. Etiology of coma and clinical status at the time of admission are likely outcome predictors. Infection is the commonest etiology for coma in all age groups .
Coma in children is recognized to be a non-specific sign with a wide potential differential diagnosis. Among various etiological factors identified for non-traumatic coma, considerable regional diversity exists in them with infectious problems suggested to be more common in developing countries. There has been few case series in developing countries with specific reference to infective etiology and there are also differences in infective agents between developing and developed countries. Similarly prediction of outcome of coma is difficult early in the course of the illness, especially in children. There have been many studies suggesting prognostic parameters of coma in adults, but limited reviews are available for children.
Etiologically it can be divided into two broad categories: those without focal neurologic signs (e.g., metabolic encephalopathies); meningitis syndromes, characterized by fever or stiff neck and an excess of cells in the spinal fluid (e.g., bacterial meningitis, subarachnoid hemorrhage); and conditions associated with prominent focal signs (e.g., stroke, cerebral hemorrhage). In most instances coma is part of an obvious medical problem such as drug ingestion, hypoxia, stroke, trauma, or liver or kidney failure. Conditions that cause sudden coma include drug ingestion, cerebral hemorrhage, trauma, cardiac arrest, epilepsy, or basilar artery embolism. Coma that appears subacutely is usually related to a preceding medical or neurologic problem, including the secondary brain swelling of a mass lesion such as tumor or cerebral infarction.
Central nervous infections are the most common cause . Toxic-metabolic, status-epilepticus, hypoxic-ischemic, intracranial bleed etc. are other main causes.
Neurological outcome is often the foremost concern of parents and physicians .Etiology of coma and clinical status at the time of presentation are the most likely predictors of outcome. Simple clinical signs have been found as good predictors of outcome .
Non-traumatic coma is an important source of morbidity and mortality in the pediatric age group. Accurate diagnosis of etiology of childhood coma in resource poor countries is complicated by overlap in clinical presentation, limited diagnostic resources, disease endemicity and co-morbidity . Considerable skill is required to distinguish the group at high risk for further deterioration, potentially leading either to death or severe handicap. This study attempts to identify the common etiological factors of pediatric comatose patients as well as the predictors of poor outcomes in these patients .
Episodes were defined on the basis of a Glasgow Coma Score (GCS) of less than 12 for more than six hours . Many acutely ill children are not fully conscious because pathologic processes may affect the parts of the central nervous system that mediate consciousness; alteration in the state of consciousness is a common feature of many different conditions.
Many of these children make a full neurological recovery. However, depending on the underlying etiology non-traumatic coma may cause considerable mortality and morbidity in pediatric age group .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children admitted in Assiut University Hospital with impaired consciousness .
Key inclusion criteria (2 listed)
- disturbed conscious level
- Children's family signed consent of approval to participate in the study
Key exclusion criteria (3 listed)
- Children aged <2 months or >18 years.
- Coma of traumatic etiology.
- Coma as part of an anticipated terminal illness.
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 |
|---|---|---|
| CT brainnoninvasive medical examination or procedure that uses specialized X-ray equipment to produce cross-sectional images of the body. | Device | – |
Primary outcome
The percentage of recovery from coma
Time frame: 1 month
clinical evaluation of the recovery symptoms and signs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
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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.
Gamal Askar, prof contact
Hanan Zaka principal investigator
World Health Organization
Questions about this trial
What is this clinical trial studying?
An observational study of Impaired Consciousness, run by Assiut University.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanan Zaka (+2010013777346, hanan.zaka@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of recovery from coma (time frame: 1 month). It is what the study was designed to measure, not a finding.
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 7 Aug 2018.