Continued Anticonvulsants After Resolution of Neonatal Seizures: a Patient-centered Comparative Effectiveness Study

Study Overview
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Brief Summary
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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.

Official Title
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Continued Anticonvulsants After Resolution of Neonatal Seizures: a Patient-centered Comparative Effectiveness Study

Conditions
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Neonatal Seizures

Intervention / Treatment
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* Other: Surveys
* Other: EEG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 0 Weeks
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Outpatient Enrollees<br>This is a cohort of 150 subjects who were previously enrolled in the Neonatal Seizure Registry, a multi-center association of institutions across the United States, They were contacted to participate in the study after discharge from the Neonatal Intensive Care Unit (NICU) but prior to the prospective follow up. They were asked to take part in all prospective follow up surveys at 12, 18, & 24 months of age. | Other: Surveys<br>* Regarding development, epilepsy, and family impact<br>* Other names: Former Neonatal Seizure Registry Subjects;|
| NICU Enrollees<br>This is a cohort of 150 subjects who were enrolled in the study prior to discharge from the NICU. They were asked to complete surveys prior to discharge from the NICU, returned to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, & completed the follow surveys at 12, 18, & 24 months of age. | Other: Surveys<br>* Regarding development, epilepsy, and family impact<br>* Other names: Former Neonatal Seizure Registry Subjects;Other: EEG<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WIDEA Neurodevelopmental Outcome Score | 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. | 24 months | 
| Number of Participants With Post-neonatal Epilepsy | 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. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay for the Neonatal Seizure Admission | Evaluation of medication exposure (dose and duration) during the admission as a predictor of the number of days the infant requires care (length of stay) | 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 | Surveys selected with the help of our Parent Partners were given at 12, 18, and 24 months to assess the impact of neonatal seizure treatment duration on parent and family quality of life and well-being. The 24 month data is presented, as they align with the primary outcome. The study team reviewed the HADS 24 month Anxiety and Depression Score range of possible scores from 0-21 (higher = more depressed/more anxious), the 24 month Transformed WHO Overall Quality of Life and General Health score range of scores 0-100 (higher=better quality of life), the 24 month Impact on Family Scale overall impact scale range from 15-60 (higher = more impact on family), the 24 month Post Traumatic Growth Inventory scale range from 0 -105 (higher = better/more growth), and the 24 month Impact of Events Scale-Revised scale range from 0 - 88 (higher score = worse impact). | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phenobarbital, EEG, family impact, neurodevelopment