Protocol Number: 04-N-0210

Title:

Towards the Establishment of Standards of Practice and the Initiation of Multi-Center, Multi-National Clinical Trials for Neonates and Children With Stroke

Number:

04-N-0210

Summary:

This multi-center collaborative study will establish a database of information about stroke in infants and children.

Children 0 to 18 years of age who: 1) have had an ischemic stroke after January 1, 2003; 2) have a history of spastic hemiplegic or quadriplegic cerebral palsy and X-ray evidence of ischemic stroke after January 1, 2003; or 3) are diagnosed with ischemic stroke defined by a new focal neurologic deficit lasting 24 hours or more and presumed due to vessel obstruction or narrowing may be eligible to participate this study.

Participating children have their medical and research records reviewed for information about their stroke. The information is gathered and entered into an internet database. Parents may be interviewed to obtain additional information, if needed. No identifying information is entered into the database, so that the child's participation remains anonymous. The resulting registry may allow physicians to better diagnose, treat, and prevent stroke in children, and will help in developing and conducting new clinical trials to study this disease.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Children, 0 to 18 years of age, with an event of ischemic stroke after January 1, 2003;

Children, 0 to 18 years of age, with a history of spastic hemiplegic or quadriplegic cerebral palsy with radiographic evidence of ischemic stroke occurring after January 1, 2003;

A diagnosis of ischemic stroke (arterial ischemic stroke or sinovenous thrombosis) as defined by a new focal neurologic deficit lasting greater than or equal to 24 hours and presumably due to a vascular process and confirmed by brain imaging, either computed tomography (CT), magnetic resonance (MR), or Doppler ultrasonography;

Informed consent of the parent; and

Informed assent of the child, when available.

EXCLUSION CRITERIA:

Preterm children (less than 36 weeks gestation);

Children greater than 18 years of age;

Children with an event of ischemic stroke prior to January 1, 2003.

Special Instructions: Currently Not Provided

Keywords:

Ischemia

Pediatric

Etiology

Treatment

Outcome

Recruitment Keywords:

Childhood Stroke

Pediatric Stroke

Ischemic Stroke

Spastic Hemiplegia

Quadriplegic Cerebral Palsy

Conditions:

Cerebrovascular Accident

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Lynch JK, et al. Report of the National Institute of Neurological Disorders and Stroke workshop on perinatal and childhood stroke. Pediatrics. 2002 Jan;109(1):116-23. PMID: 11773550

deVeber GA, et al. Neurologic outcome in survivors of childhood arterial ischemic stroke and sinovenous thrombosis. J Child Neurol. 2000 May;15(5):316-24. PMID: 10830198

deVeber G, et. al. Cerebral sinovenous thrombosis in children. N Engl J Med. 2001 Aug 9;345(6):417-23. PMID: 11496852

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/23/2004