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Blood Sugars in Children With Idiopathic Seizures.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00279851
Recruitment Status : Withdrawn
First Posted : January 20, 2006
Last Update Posted : January 6, 2021
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City

Brief Summary:
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 or disease
Seizures Hypoglycemia Hyperammonemia

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prevalence of Hypoglycemia and/or Hyperinsulinism/Hyperammonemia Syndrome in Patients With Idiopathic Seizures.
Actual Study Start Date : February 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with idiopathic seizure disorders under age 18 years of age.

Inclusion Criteria:

  • The inclusion criteria will be patients with idiopathic seizure disorders.
  • The age range will be from birth to 17 years of age.
  • Study subjects may be on anti-convulsants; the study does not alter current drug therapy.

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:

    1. congenital causes (CNS malformation, cerebral palsy)
    2. CNS infection toxic/known metabolic abnormality
    3. CNS neoplasm perinatal insults (birth trauma, asphyxia/hypoxia),
    4. traumatic
    5. All others who have an anatomic or known biochemical lesion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279851

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United States, Missouri
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
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Principal Investigator: Chetanbabu M Patel, MD Children's Mercy Hospital Kansas City

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Responsible Party: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT00279851    
Other Study ID Numbers: 05046
First Posted: January 20, 2006    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021
Keywords provided by Children's Mercy Hospital Kansas City:
idiopathic seizure
hyperammonemia/hyperinsulinism syndrome
Additional relevant MeSH terms:
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Neurologic Manifestations
Nervous System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pathologic Processes