Clinical trial NCT00279851: Blood Sugars in Children With Idiopathic Seizures.
Official title: Prevalence of Hypoglycemia and/or Hyperinsulinism/Hyperammonemia Syndrome in Patients With Idiopathic Seizures.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Seizures
Hypoglycemia
Hyperammonemia
Keywords: idiopathic seizure
hypoglycemia
hyperammonemia/hyperinsulinism syndrome
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2006-01-20
Enrollment: 0
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with idiopathic seizure disorders under age 18 years of age.

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Chetanbabu M Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
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