Continued Anticonvulsants After Resolution of Neonatal Seizures: a Patient-centered Comparative Effectiveness Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 11
- 主要终点
- WIDEA Neurodevelopmental Outcome Score
研究概览
简要总结
The purpose of this study is to examine whether the duration of treatment with phenobarbital has an impact on neurodevelopmental and epilepsy outcomes, as well as parent and family well-being, after neonatal seizures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Weeks 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates <44 weeks corrected age at seizure onset
- •Seizures due to acute brain injury
- •Parent(s) who are English or Spanish literate (with assistance of interpreter)
排除标准
- •Neonates at risk for adverse outcome independent of seizures and underlying brain injury
- •Neonates with mild, temporary causes for seizures
- •Newborns with neonatal-onset epilepsy syndromes
- •Neonates who do not survive the initial hospital admission
- •Neonates will not be excluded based on race, ethnicity, gender or gestational age
结局指标
主要结局
WIDEA Neurodevelopmental Outcome Score
时间窗: 24 months
The Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA FS) allowed us to compare the functional development between newborns who received short duration phenobarbital treatment and prolonged phenobarbital treatment. There were 50 questions with response options of 1(Never) to 4(all the time). WIDEA range was on a scale from 50-200 (At 24 months, the normal population mean score is 172±10).The higher the score the better the child's developmental function. Mean scores were calculated using data from any participant who completed surveys at 24 months.
Number of Participants With Post-neonatal Epilepsy
时间窗: 24 months
The diagnosis of epilepsy and the details of seizure types and frequencies were determined by telephone interview with the parent and corroborated by medical record review.
次要结局
- Length of Stay for the Neonatal Seizure Admission(length of stay, measured in days, will be recorded during a chart review when the child is 12 months of age)
- Impact of Treatment Duration on Parent and Family Well-being(24 months)
研究者
Renée Shellhaas, MD
Clinical Professor
University of Michigan