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Sponsored by: |
Children's Mercy Hospital Kansas City |
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Information provided by: | Children's Mercy Hospital Kansas City |
ClinicalTrials.gov Identifier: | NCT00279851 |
The purpose of this study is to determine if there is a significant percentage of children with the diagnosis of idiopathic seizures who have undiagnosed or unrecognized hypoglycemia (low blood sugar).
Condition |
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Seizures Hypoglycemia Hyperammonemia |
Study Type: | Observational |
Study Design: | Screening, Cross-Sectional, Defined Population, Prospective Study |
Official Title: | Prevalence of Hypoglycemia and/or Hyperinsulinism/Hyperammonemia Syndrome in Patients With Idiopathic Seizures. |
Estimated Enrollment: | 225 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | August 2007 |
Convulsive disorders are among the most frequently occurring neurologic conditions in children. Idiopathic seizures are the most common (67.6%) type of seizure seen in the 0-15 year age group. The highest incidence is in the first year of life. In the United States, 5 percent of individuals experience a seizure of some type by the age of 20.
Seizures have multiple etiologies. These include hypoglycemia, congenital causes, toxic/metabolic causes, infection, neoplasm, perinatal causes, and trauma. The medical evaluation often includes blood work, imaging of the brain, and performing an electroencephalogram. Currently, there is no consensus as to the work-up of children presenting with unprovoked seizures.
Hypoglycemia presents with a wide spectrum of symptoms and severity. In children, hypoglycemia can lead to seizures and coma. In neonates and infants, however, the symptoms are even more varied and nonspecific. They can include cyanotic spells, apnea, respiratory distress, refusal to feed, and myoclonic jerks. The varied symptoms of hypoglycemia make the disorder difficult to diagnose.
The study will have parents checking blood sugars for 14 days and a one time ammonia level. Blood sugar checks will be first thing in the morning and one hour after a meal. If the study identifies a subset of patients with idiopathic seizures who have hypoglycemia, this finding may have implications for future glucose screening recommendations.
Ages Eligible for Study: | up to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The exclusion criteria includes patients with known causes of seizure disorders, including those with an underlying risk factor predisposing them to seizures. The risk factors are:
Contact: Chetanbabu M Patel, MD | 816-234-1660 ext 6589 | chpatel@cmh.edu |
United States, Missouri | |
Children's Mercy Hospitals and Clinics | Recruiting |
Kansas City, Missouri, United States, 64108 |
Principal Investigator: | Chetanbabu M Patel, MD | Children's Mercy Hospital |
Study ID Numbers: | 05046 |
Study First Received: | January 18, 2006 |
Last Updated: | September 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00279851 |
Health Authority: | United States: Institutional Review Board |
idiopathic seizure hypoglycemia hyperammonemia/hyperinsulinism syndrome |
Signs and Symptoms Hyperinsulinism Metabolic Diseases Epilepsy Seizures Neurologic Manifestations |
Central Nervous System Diseases Metabolic disorder Brain Diseases Glucose Metabolism Disorders Hypoglycemia Hyperammonemia |
Pathologic Processes Nervous System Diseases |