Blood Sugars in Children With Idiopathic Seizures.

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ClinicalTrials.gov Identifier: NCT00279851

Recruitment Status : Withdrawn

First Posted : January 20, 2006

Last Update Posted : January 6, 2021

Sponsor:

Information provided by (Responsible Party):

Children's Mercy Hospital Kansas City

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
Seizures Hypoglycemia Hyperammonemia

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

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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 :	February 2006
Actual Primary Completion Date :	February 2007
Actual Study Completion Date :	February 2007

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Carbonic anhydrase VA deficiency

MedlinePlus related topics: Hypoglycemia Seizures

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	up to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with idiopathic seizure disorders under age 18 years of age.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279851

Locations

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United States, Missouri
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108

Sponsors and Collaborators

Children's Mercy Hospital Kansas City

Investigators

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

More Information

Publications:

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.

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

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

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.

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.

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.

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.

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

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.

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.

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.

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.

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Responsible Party:	Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:	NCT00279851
Other Study ID Numbers:	05046
First Posted:	January 20, 2006 Key Record Dates
Last Update Posted:	January 6, 2021
Last Verified:	January 2021

Keywords provided by Children's Mercy Hospital Kansas City:


idiopathic seizure hypoglycemia hyperammonemia/hyperinsulinism syndrome

Additional relevant MeSH terms:

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Seizures Hypoglycemia Hyperinsulinism Hyperammonemia Neurologic Manifestations	Nervous System Diseases Glucose Metabolism Disorders Metabolic Diseases Pathologic Processes

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