Blood Sugars in Children With Idiopathic Seizures.

Withdrawn

• Conditions: Seizures; Hypoglycemia; Hyperammonemia

• Registration Number: NCT00279851
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2006-01-18
• Study First Submitted QC: 2006-01-18
• Study First Posted: 2006-01-20
• Study Start: 2006-02
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-05
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Children's Mercy Hospitals and Clinics; 🇺🇸 Kansas City, Missouri, United States