NCT00021866

Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy

Neurodevelopmental Effects of Antiepileptic Drugs II: the NEAD Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 331 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if antiepileptic drugs (AEDs) differ in their neurodevelopmental effects. Specifically, do the children of the women with epilepsy differ in their behavioral and cognitive development depending on which AED their mother takes during pregnancy?

Detailed description

This is a prospective investigation enrolling 285 to 380 women with epilepsy during the first two trimesters of their pregnancies. There are 25 clinical centers as well as the database center. The women will be taking one of the following AEDs: carbamazepine, phenytoin, valproate, or lamotrigine. Cognitive and behavioral testing of the child will be done up to the age of 6 years. The study does not change the woman's doctor and does not interfere with the care of the treating physician.

Conditions

• Epilepsy
• Seizure
• Cognition Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Differential Abilities Scale	IQ measurement at 3, 4.5 and 6 years of age
BEHAVIORAL	Neuropsychological Testing	Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age

Timeline

• Start date: 2000-09-01
• Primary completion: 2010-08-01
• Completion: 2012-08-01
• First posted: 2001-08-10
• Last updated: 2013-11-11

Locations

21 sites across 2 countries: United States, United Kingdom