Stroke With HemiparesisNCT02129491
National Egyptian Network Pediatric Stroke and Hemiplegia Registry
An observational study of Stroke With Hemiparesis and Perinatal Stroke, run by Ain Shams University at 1 site in Egypt.
Trial summary
Our aim is to establish multi-center national Egyptian database of information about cerebrovascular stroke and hemiplegia in infants and children from 0 to 18 years of age. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Stroke With Hemiparesis, Perinatal Stroke, Focal Neurologic Deficits
- How many people
- 1,000 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2014to Dec 2021
- How long will I take part?
- 10 Years
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All children from birth to 18 years of age with acute stroke presented by focal neurological signs confirmed by neuroradiology CT or MRI. All children with hemiplegia till the age of 18 years.
Who may be able to join
- Focal neurological deficit of acute onset lasting greater than 20 minutes. And CT or MRI showing infarct in location consistent with neurological signs and symptoms
- Hemiplegia
Who cannot join
- Cerebral haemorrhage not associated with ischemic infarct.
- Hypoxic ischemic event with diffuse or bilateral infarction alone.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University
Cairo, Abassia, 11381
Mohsen S Elalfy, MD, PhD, elalfym@hotmail.com
Sahar MA Hassanein, MD, PhD
About this study
Our aim is to establish multi-center national Egyptian database of information about cerebrovascular stroke and hemiplegia in infants and children from 0 to 18 years of age.
Read the detailed description
Aims: An open-ended multi-center, national Egyptian study to collect and analyze data for children with cerebrovascular stroke and hemiplegia .
Participants: Eligible infants and children with stroke and hemiplegia.
DESIGN: This study is a prospective cohort study.
Primary outcome measure: Initial acute stroke clinical and radiological presentation, recurrent stroke, mortality, and neurologic deficits in the acute stage, participants will be followed for the duration of hospital stay, an expected average of 6 weeks
- Keywords
- stroke, Congenital stroke, neonatal, hemiplegia
- Medical subject headings
- Neurologic Manifestations, Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Stroke and Hemiplegia | Any infant or child with acute stroke or hemiplegia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival or neurologic deficit after acute cerebrovascular stroke.
Children with acute stroke will be followed till either death or discharge from hospital, all clinical, radiological and therapeutic data will be collected.
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Secondary outcomes (1)
Long term neurological deficit
Post-stroke pediatric gross and fine motor function will be assessed.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke With HemiparesisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar M.A. Hassanein, MD, Ain Shams University
- Investigators
- Sahar MA Hassanein, MD, PhD, Study chair, Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129491
- Sponsor's protocol ID
- NENPSHR
- Status last verified
- May 2014
- First submitted
- 15 Apr 2014
- Last updated
- 2 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Egyptian Network Pediatric Stroke and Hemiplegia Registry
- ClinicalTrials.gov ID
- NCT02129491
- Acronym / sponsor ID
- NENPSHR
- Keywords
- stroke, Congenital stroke, neonatal, hemiplegia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 2 May 2014 (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.
Our aim is to establish multi-center national Egyptian database of information about cerebrovascular stroke and hemiplegia in infants and children from 0 to 18 years of age.
Detailed description
Aims: An open-ended multi-center, national Egyptian study to collect and analyze data for children with cerebrovascular stroke and hemiplegia .
Participants: Eligible infants and children with stroke and hemiplegia.
DESIGN: This study is a prospective cohort study.
Primary outcome measure: Initial acute stroke clinical and radiological presentation, recurrent stroke, mortality, and neurologic deficits in the acute stage, participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Stroke and Hemiplegia | – | –Any infant or child with acute stroke or hemiplegia |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All children from birth to 18 years of age with acute stroke presented by focal neurological signs confirmed by neuroradiology CT or MRI. All children with hemiplegia till the age of 18 years.
Key inclusion criteria (2 listed)
- Focal neurological deficit of acute onset lasting greater than 20 minutes. And CT or MRI showing infarct in location consistent with neurological signs and symptoms
- Hemiplegia
Key exclusion criteria (2 listed)
- Cerebral haemorrhage not associated with ischemic infarct.
- Hypoxic ischemic event with diffuse or bilateral infarction alone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival or neurologic deficit after acute cerebrovascular stroke.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Children with acute stroke will be followed till either death or discharge from hospital, all clinical, radiological and therapeutic data will be collected.
1 secondary outcome
Long term neurological deficit
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2014.
- Faculty of Medicine, Ain Shams UniversityLink provided by the sponsor.
- Ain Shams University web siteLink provided by the sponsor.
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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.
Sahar MA Hassanein, MD, PhD study chair
Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University
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 Stroke With Hemiparesis and Perinatal Stroke, run by Ain Shams University at 1 site in Egypt.
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 2 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 2 May 2014. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sahar MA Hassanein, MD, PhD (201223183943, saharhassanein@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival or neurologic deficit after acute cerebrovascular stroke. (time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks). 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 2 May 2014.