Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353886
Status:
COMPLETED
Last Update Posted:
2007-07-23
First Post:
2006-07-17
Brief Title:
Study of Antiepileptic Drug Effects on Child Development
Sponsor:
Augusta University
Organization:
Augusta University
Study Overview
Official Title:
Retrospective Study of In Utero Antiepileptic Drug Effects in Neurodevelopment
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The specific aim of this study is to determine if in utero exposure produces differential antiepileptic drug AED effects on subsequent cognitive abilities and behavioral abnormalities in children
Detailed Description:
Subject groups will include 120 children 6 - 16 yearold of women with epilepsy who were exposed to one of the following anti-epileptic drugs during the mothers pregnancy with that child CarbamazepineTegretol ValproateDepakote and PhenytoinDilantin
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 mothers pregnancy other than the target AEDs in monotherapy if the child has or has had a serious brain injury eg severe head trauma or serious medical illness eg cancer which is unrelated to AED exposure and may affect the childs cognitive abilities Other exclusion criteria include maternal IQ 70 mother has a progressive brain lesion eg tumor or mother had serious medical illness or complication during this childs 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 eg Ritalin for 24 hours prior to testing if heshe 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 Childrens 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 Conners 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 ie 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
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 mothers pregnancy other than the target AEDs in monotherapy if the child has or has had a serious brain injury eg severe head trauma or serious medical illness eg cancer which is unrelated to AED exposure and may affect the childs cognitive abilities Other exclusion criteria include maternal IQ 70 mother has a progressive brain lesion eg tumor or mother had serious medical illness or complication during this childs 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 eg Ritalin for 24 hours prior to testing if heshe 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 Childrens 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 Conners 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None