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Impaired ConsciousnessNCT03618745

Outcome Predictors of Non Traumatic Coma in Children

An observational study of Impaired Consciousness, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

+201111686162

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 .

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.

  1. 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.

  1. First posted7 Aug 2018
  2. Study start1 Sep 2018 (estimated)
  3. Primary completion1 Sep 2019 (estimated)
  4. Study completion1 Dec 2019 (estimated)

Resources

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)
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

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.

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