Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT00279851
Status:
WITHDRAWN
Last Update Posted:
2021-01-06
First Post:
2006-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Blood Sugars in Children With Idiopathic Seizures.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}, {'id': 'D007003', 'term': 'Hypoglycemia'}, {'id': 'D022124', 'term': 'Hyperammonemia'}, {'id': 'C538375', 'term': 'Hyperinsulinemic hypoglycemia, familial, 6'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-05', 'studyFirstSubmitDate': '2006-01-18', 'studyFirstSubmitQcDate': '2006-01-18', 'lastUpdatePostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['idiopathic seizure', 'hypoglycemia', 'hyperammonemia/hyperinsulinism syndrome'], 'conditions': ['Seizures', 'Hypoglycemia', 'Hyperammonemia']}, 'referencesModule': {'references': [{'pmid': '11241047', 'type': 'BACKGROUND', '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. doi: 10.1067/mpd.2001.111818.'}, {'pmid': '8275976', 'type': 'BACKGROUND', 'citation': 'Hauser WA. The prevalence and incidence of convulsive disorders in children. Epilepsia. 1994;35 Suppl 2:S1-6. doi: 10.1111/j.1528-1157.1994.tb05932.x.'}, {'pmid': '15157593', 'type': 'BACKGROUND', 'citation': 'Sperling MA, Menon RK. Differential diagnosis and management of neonatal hypoglycemia. Pediatr Clin North Am. 2004 Jun;51(3):703-23, x. doi: 10.1016/j.pcl.2004.01.014.'}, {'pmid': '15643315', 'type': 'BACKGROUND', '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. doi: 10.1097/01.pec.0000150980.94571.10.'}, {'pmid': '12921452', 'type': 'BACKGROUND', '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. doi: 10.1177/000992280304200605.'}, {'pmid': '10980722', 'type': 'BACKGROUND', '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. doi: 10.1212/wnl.55.5.616.'}, {'pmid': '15756227', 'type': 'BACKGROUND', '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. doi: 10.1016/j.jpeds.2004.10.040.'}, {'pmid': '1425495', 'type': 'BACKGROUND', 'citation': 'Hauser WA. Seizure disorders: the changes with age. Epilepsia. 1992;33 Suppl 4:S6-14. doi: 10.1111/j.1528-1157.1992.tb06222.x.'}, {'pmid': '8040784', 'type': 'BACKGROUND', '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. doi: 10.1016/s0022-3476(94)70218-7.'}, {'pmid': '3120144', 'type': 'BACKGROUND', '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. doi: 10.1203/00006450-198711000-00003.'}, {'pmid': '15751925', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '14614623', 'type': 'BACKGROUND', '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. doi: 10.1007/s00431-003-1352-2. Epub 2003 Nov 12.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nSeizures 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.\n\nHypoglycemia 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with idiopathic seizure disorders under age 18 years of age.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The inclusion criteria will be patients with idiopathic seizure disorders.\n* The age range will be from birth to 17 years of age.\n* Study subjects may be on anti-convulsants; the study does not alter current drug therapy.\n\nExclusion Criteria:\n\n* 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:\n\n 1. congenital causes (CNS malformation, cerebral palsy)\n 2. CNS infection toxic/known metabolic abnormality\n 3. CNS neoplasm perinatal insults (birth trauma, asphyxia/hypoxia),\n 4. traumatic\n 5. All others who have an anatomic or known biochemical lesion.'}, 'identificationModule': {'nctId': 'NCT00279851', 'briefTitle': 'Blood Sugars in Children With Idiopathic Seizures.', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Prevalence of Hypoglycemia and/or Hyperinsulinism/Hyperammonemia Syndrome in Patients With Idiopathic Seizures.', 'orgStudyIdInfo': {'id': '05046'}}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospitals and Clinics", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Chetanbabu M Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Mercy Hospital Kansas City"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}