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Blood Sugars in Children With Idiopathic Seizures.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Children's Mercy Hospital Kansas City.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00279851
First received: January 18, 2006
Last updated: September 6, 2006
Last verified: September 2006
  Purpose

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
Seizures
Hypoglycemia
Hyperammonemia

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: Prevalence of Hypoglycemia and/or Hyperinsulinism/Hyperammonemia Syndrome in Patients With Idiopathic Seizures.

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Estimated Enrollment: 225
Study Start Date: February 2006
Estimated Study Completion Date: August 2007
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.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279851

Contacts
Contact: Chetanbabu M Patel, MD 816-234-1660 ext 6589 chpatel@cmh.edu

Locations
United States, Missouri
Children's Mercy Hospitals and Clinics Recruiting
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
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00279851     History of Changes
Other Study ID Numbers: 05046
Study First Received: January 18, 2006
Last Updated: September 6, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
idiopathic seizure
hypoglycemia
hyperammonemia/hyperinsulinism syndrome

Additional relevant MeSH terms:
Hyperammonemia
Hyperinsulinism
Hypoglycemia
Seizures
Brain Diseases
Central Nervous System Diseases
Epilepsy
Glucose Metabolism Disorders
Metabolic Diseases
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014