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

University of Michigan303 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

303

Conditions

Neonatal Seizures

Interventions

SurveysOTHER

Regarding development, epilepsy, and family impact

EEGOTHER

Eligibility

Sex: ALLMin age: 0 WeeksMax age: 24 Months

Medical Language ↔ Plain English

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

Locations (11)

University of California, San Francisco

San Francisco, California, United States

Stanford University

Stanford, California, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 24 months

Secondary Outcomes

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)

Time frame: 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).

Data from ClinicalTrials.gov

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