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

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ClinicalTrials.gov Identifier: NCT02789176
Recruitment Status : Completed
First Posted : June 2, 2016
Results First Posted : November 5, 2020
Last Update Posted : December 4, 2020
Sponsor:
Collaborators:
University of California, San Francisco
Boston Children's Hospital
Children's Hospital of Philadelphia
Children's National Research Institute
Massachusetts General Hospital
Patient-Centered Outcomes Research Institute
Stanford University
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Duke University
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Renée Shellhaas, MD, University of Michigan

Tracking Information
First Submitted Date May 19, 2016
First Posted Date June 2, 2016
Results First Submitted Date October 13, 2020
Results First Posted Date November 5, 2020
Last Update Posted Date December 4, 2020
Study Start Date October 2016
Actual Primary Completion Date March 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 20, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: May 26, 2016)
  • WIDEA Neurodevelopmental Outcome Score [ Time Frame: 12 months ]
    The Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA FS) will allow us to compare the functional development between newborns who received short duration phenobarbital treatment and prolonged phenobarbital treatment
  • Incidence of Post-neonatal Epilepsy [ Time Frame: 12 months ]
    a simple questionnaire designed to define the rate and severity of epilepsy
Change History
Current Secondary Outcome Measures
 (submitted: October 13, 2020)
  • 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)
  • 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).
Original Secondary Outcome Measures
 (submitted: May 26, 2016)
  • Impact of treatment duration on length of stay in the NICU [ Time Frame: length of stay in the NICU, 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 NICU care (length of NICU stay)
  • Impact of Treatment Duration on Parent and Family Well-being [ Time Frame: 24 months ]
    Surveys created with the help of our Parent Partners will be 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 nature of comparison analysis is still to be determined with our Parent Advisory Board.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Continued Anticonvulsants After Resolution of Neonatal Seizures: a Patient-centered Comparative Effectiveness Study
Official Title Continued Anticonvulsants After Resolution of Neonatal Seizures: a Patient-centered Comparative Effectiveness Study
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Newborns with seizures who were admitted at one of the participating children's hospitals
Condition Neonatal Seizures
Intervention
  • Other: Surveys
    Regarding development, epilepsy, and family impact
    Other Name: Former Neonatal Seizure Registry Subjects
  • Other: EEG
Study Groups/Cohorts
  • Outpatient Enrollees
    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.
    Intervention: Other: Surveys
  • NICU Enrollees
    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.
    Interventions:
    • Other: Surveys
    • Other: EEG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 13, 2020)
303
Original Estimated Enrollment
 (submitted: May 26, 2016)
300
Actual Study Completion Date March 24, 2020
Actual Primary Completion Date March 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 24 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02789176
Other Study ID Numbers HUM00114541
1507-31187 ( Other Identifier: PCORI project number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Will be posted on pcori.org
Responsible Party Renée Shellhaas, MD, University of Michigan
Study Sponsor University of Michigan
Collaborators
  • University of California, San Francisco
  • Boston Children's Hospital
  • Children's Hospital of Philadelphia
  • Children's National Research Institute
  • Massachusetts General Hospital
  • Patient-Centered Outcomes Research Institute
  • Stanford University
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Duke University
  • Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Renée A Shellhaas, MD, MS University of Michigan
Principal Investigator: Hannah C Glass, MDCM, MAS University of California, San Francisco
PRS Account University of Michigan
Verification Date November 2020