Study of Antiepileptic Drug Effects on Child Development
NCT ID: NCT00353886
Last Updated: 2007-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
81 participants
OBSERVATIONAL
2002-09-30
2007-06-30
Brief Summary
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Detailed Description
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In addition to the children, their mother, father and a primary relative of the mother will also be asked participate in the study. Children cannot be enrolled if they were exposed to another known teratogen during their mother's pregnancy other than the target AEDs in monotherapy; if the child has or has had a serious brain injury (e.g. severe head trauma) or serious medical illness (e.g. cancer), which is unrelated to AED exposure and may affect the child's cognitive abilities. Other exclusion criteria include, maternal IQ \<70; mother has a progressive brain lesion (e.g. tumor) or mother had serious medical illness or complication during this child's pregnancy, which was unrelated to AED or epilepsy, history or maternal alcohol or drug abuse in past 12 months, and history of child abuse. If possible, the child should be off sympathomimetic medications (e.g. Ritalin) for 24 hours prior to testing if he/she is being treated for ADD or ADHD.
Procedures: The primary test is the IQ (TONI-3) in the children. Additional tests in the children include the Peabody Picture Vocabulary Test -3; WRAT spelling, math \& reading subtests; Children's Memory Scale: story memory subtest (immediate, delayed, \& delayed recognition subscales); WISC-III coding subtest; Behavioral Assessment System for Children (parent and teacher scales) and the Conner's Rating Scale - (parent and teacher rating scales).
Collected information about the mother includes social and medical factors of the mother, specifically age, type of epilepsy, AED \& estimated months exposed and average dose during pregnancy, estimated seizure frequency during pregnancy (by types including status), any other major medical illnesses during pregnancy, primary language, education level and socioeconomic status. The mother will also have an IQ (TONI-3) test.
Collected information about the child include: age, gender, gestational age at birth (i.e. full or pre-term), birth order \& # sibs, primary language at home, Birth defects, Hx ADD or ADHD; other major medical illnesses (include perinatal complications); special education requirements of the child; and remedial math or reading requirements of child.
Collected information about the father and primary relative include: age, relationship to mother (for primary relative), primary language, education level, socioeconomic status, any major medical illnesses (especially those which could affect IQ). The relative and father will also have an IQ (TONI-3) test.
Conditions
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Study Design
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DEFINED_POPULATION
OTHER
Interventions
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TONI-3
WRAT-3
Connor's Rating Scales PRS & TRS
Peabody Picture Vocabulary Test
Children's Memory Scale
WISC-3
Behavioral Assessment System for Children PRS & TRS
Eligibility Criteria
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Inclusion Criteria
2. In utero exposure should be at least 6 months.
3. Children of the same mother may be enrolled if each child was exposed to a different AED monotherapy (e.g. carbamazepine, phenytoin, or valproate) during their mother's pregnancy.
4. Mother's primary language should be English or Spanish.
5. The mother was 18-35 years of age when the child was born (inclusive).
Exclusion Criteria
2. Child is presently on a centrally active medication other than sympathomimetics (e.g. Ritalin) for ADD or ADHD. Child should be off the sympathomimetic for at least 24 hours prior to testing.
3. Child has or has had a serious brain injury (e.g., severe head trauma) or serious medical illness (e.g., cancer) unrelated to AED exposure, which may affect the child's cognitive abilities.
4. Mother has IQ \< 70.
5. Mother has a progressive brain lesion (e.g., tumor).
6. Mother had serious medical illness or complication during this child's pregnancy, which was unrelated to AED or epilepsy.
7. Mother has known history of drug or alcohol abuse within the previous 12 months or has sequelae of drug abuse.
8. There is a known history of child abuse.
6 Years
16 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Augusta University
OTHER
Principal Investigators
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Gregory Lee, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Augusta University
Kimford J. Meador, MD
Role: STUDY_CHAIR
University of Florida
Locations
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University of Southern California
Los Angeles, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
Boston University
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Minnesota Epilepsy Group
Saint Paul, Minnesota, United States
Case Western Reserve University
Cleveland, Ohio, United States
University of Aberdeen
Aberdeen, , United Kingdom
Countries
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Related Links
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Related Info
Other Identifiers
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RNEAD
Identifier Type: -
Identifier Source: org_study_id