Study of Antiepileptic Drug Effects on Child Development
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Observational

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 year/old) of women with epilepsy, who were
      exposed to one of the following anti-epileptic drugs during the mother's pregnancy with that
      child: Carbamazepine/Tegretol, Valproate/Depakote, and Phenytoin/Dilantin.

      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.
    

Intervention name(s): 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
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure; Procedure; Procedure
Observational model: Defined Population
Time perspective: Other
Keywords: Retrospective; Epilepsy; Antiepileptic Drugs; Behavioral Development; Intellectual Development