Blood Sugars in Children With Idiopathic Seizures.

Hypoglycemia Clinical Trial

Official title:

Prevalence of Hypoglycemia and/or Hyperinsulinism/Hyperammonemia Syndrome in Patients With Idiopathic Seizures.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00279851
• Other study ID #: 05046
• Status: Withdrawn
• Start date: February 2006
• Est. completion date: February 2007

Study information

• Verified date: January 2021
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperammonemia
• Hyperinsulinism
• Hypoglycemia
• Seizures

Locations

Country	Name	City	State
United States	Children's Mercy Hospitals and Clinics	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

References & Publications (12)

al-Hosani H, Salah M, Saade D, Osman H, al-Zahid J. United Arab Emirates National Newborn Screening Programme: an evaluation 1998-2000. East Mediterr Health J. 2003 May;9(3):324-32. — View Citation

Hauser WA. Seizure disorders: the changes with age. Epilepsia. 1992;33 Suppl 4:S6-14. Review. — View Citation

Hauser WA. The prevalence and incidence of convulsive disorders in children. Epilepsia. 1994;35 Suppl 2:S1-6. — View Citation

Hirtz D, Ashwal S, Berg A, Bettis D, Camfield C, Camfield P, Crumrine P, Elterman R, Schneider S, Shinnar S. Practice parameter: evaluating a first nonfebrile seizure in children: report of the quality standards subcommittee of the American Academy of Neurology, The Child Neurology Society, and The American Epilepsy Society. Neurology. 2000 Sep 12;55(5):616-23. — View Citation

Hsu BY, Kelly A, Thornton PS, Greenberg CR, Dilling LA, Stanley CA. Protein-sensitive and fasting hypoglycemia in children with the hyperinsulinism/hyperammonemia syndrome. J Pediatr. 2001 Mar;138(3):383-9. — View Citation

Melegh B, Pap M, Morava E, Molnar D, Dani M, Kurucz J. Carnitine-dependent changes of metabolic fuel consumption during long-term treatment with valproic acid. J Pediatr. 1994 Aug;125(2):317-21. — View Citation

Nishida N, Sugimoto T, Araki A, Woo M, Sakane Y, Kobayashi Y. Carnitine metabolism in valproate-treated rats: the effect of L-carnitine supplementation. Pediatr Res. 1987 Nov;22(5):500-3. — View Citation

Raizen DM, Brooks-Kayal A, Steinkrauss L, Tennekoon GI, Stanley CA, Kelly A. Central nervous system hyperexcitability associated with glutamate dehydrogenase gain of function mutations. J Pediatr. 2005 Mar;146(3):388-94. — View Citation

Schweitzer-Krantz S. Early diagnosis of inherited metabolic disorders towards improving outcome: the controversial issue of galactosaemia. Eur J Pediatr. 2003 Dec;162 Suppl 1:S50-3. Epub 2003 Nov 12. Review. — View Citation

Sperling MA, Menon RK. Differential diagnosis and management of neonatal hypoglycemia. Pediatr Clin North Am. 2004 Jun;51(3):703-23, x. Review. — View Citation

Valencia I, Sklar E, Blanco F, Lipsky C, Pradell L, Joffe M, Legido A. The role of routine serum laboratory tests in children presenting to the emergency department with unprovoked seizures. Clin Pediatr (Phila). 2003 Jul-Aug;42(6):511-7. — View Citation

Vilke GM, Castillo EM, Ray LU, Murrin PA, Chan TC. Evaluation of pediatric glucose monitoring and hypoglycemic therapy in the field. Pediatr Emerg Care. 2005 Jan;21(1):1-5. — View Citation

* Note: There are 12 references in all — Click here to view all references