Blood Sugars in Children With Idiopathic Seizures.

Sponsor
Children's Mercy Hospital Kansas City (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00279851
Collaborator
(none)
0
1
12
0

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    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 :
    Feb 1, 2006
    Actual Primary Completion Date :
    Feb 1, 2007
    Actual Study Completion Date :
    Feb 1, 2007

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A to 17 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Children's Mercy Hospitals and Clinics Kansas City Missouri United States 64108

      Sponsors and Collaborators

      • Children's Mercy Hospital Kansas City

      Investigators

      • Principal Investigator: Chetanbabu M Patel, MD, Children's Mercy Hospital Kansas City

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      Children's Mercy Hospital Kansas City
      ClinicalTrials.gov Identifier:
      NCT00279851
      Other Study ID Numbers:
      • 05046
      First Posted:
      Jan 20, 2006
      Last Update Posted:
      Jan 6, 2021
      Last Verified:
      Jan 1, 2021
      Keywords provided by Children's Mercy Hospital Kansas City
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Jan 6, 2021