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Completed

NCT Number: NCT02789176

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

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.

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Key information

Conditions

Age range

0 week–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surveys

Other

Regarding development, epilepsy, and family impact

Other names: Former Neonatal Seizure Registry Subjects

EEG

Other

Primary outcomes

  1. WIDEA Neurodevelopmental Outcome Score

    Time frame: 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.

  2. Number of Participants With Post-neonatal Epilepsy

    Time frame: 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.

Secondary outcomes

  1. Length of Stay for the Neonatal Seizure Admission

    Time frame: length of stay, measured in days, will be recorded during a chart review when the child is 12 months of age

    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)

  2. Impact of Treatment Duration on Parent and Family Well-being

    Time frame: 24 months

    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).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Boston Children's Hospital
  • Brigham and Women's Hospital
  • Children's Hospital Medical Center, Cincinnati
  • Children's Hospital of Philadelphia
  • Children's National Research Institute
  • Duke University
  • Massachusetts General Hospital
  • Patient-Centered Outcomes Research Institute
  • Stanford University
  • University of California, San Francisco

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 2, 2016
Registry last updated
Dec 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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