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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment
Neonatal Seizures Other: Surveys Other: EEG

Study Design
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Study Type : Observational
Actual Enrollment : 303 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Continued Anticonvulsants After Resolution of Neonatal Seizures: a Patient-centered Comparative Effectiveness Study
Study Start Date : October 2016
Actual Primary Completion Date : March 24, 2020
Actual Study Completion Date : March 24, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Other: Surveys
Regarding development, epilepsy, and family impact
Other Name: Former Neonatal Seizure Registry Subjects
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.
 Other: Surveys
Regarding development, epilepsy, and family impact
Other Name: Former Neonatal Seizure Registry Subjects

Other: EEG


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   0 Weeks to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Newborns with seizures who were admitted at one of the participating children's hospitals
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789176


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Stanford University
Stanford, California, United States, 94304
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, North Carolina
Duke University
Durham, North Carolina, United States, 227710
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Michigan
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
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Principal Investigator: Renée A Shellhaas, MD, MS University of Michigan
Principal Investigator: Hannah C Glass, MDCM, MAS University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by Renée Shellhaas, MD, University of Michigan:
Study Protocol and Statistical Analysis Plan  [PDF] April 20, 2020

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Renée Shellhaas, MD, Clinical Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02789176    
Other Study ID Numbers: HUM00114541
1507-31187 ( Other Identifier: PCORI project number )
First Posted: June 2, 2016    Key Record Dates
Results First Posted: November 5, 2020
Last Update Posted: December 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will be posted on pcori.org
Keywords provided by Renée Shellhaas, MD, University of Michigan:
Phenobarbital
EEG
family impact
neurodevelopment
Additional relevant MeSH terms:
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Seizures
Neurologic Manifestations
Nervous System Diseases