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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 : Active, not recruiting
First Posted : June 2, 2016
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
University of California, San Francisco
Boston Children’s Hospital
Children's Hospital of Philadelphia
Children's 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

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

Detailed Description:
The Nature of the comparison analysis for parent and family well-being is yet to be determined with our Parent Partner Advisory Board.

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Study Type : Observational
Actual Enrollment : 307 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
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

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 will be contacted to participate in the study after discharge from the Neonatal Intensive Care Unit (NICU) but prior to the prospective follow up. They will be 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 will be enrolled in the study prior to discharge from the NICU. They will be asked to complete surveys prior to discharge from the NICU, return to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, & complete 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



Primary Outcome Measures :
  1. WIDEA Neurodevelopmental Outcome Score [ Time Frame: 24 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

  2. Incidence of post-neonatal epilepsy [ Time Frame: 24 months ]
    a simple questionnaire designed to define the rate and severity of epilepsy


Secondary Outcome Measures :
  1. 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)

  2. 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.



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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Newborns with seizures who are 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

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 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

Additional Information:
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Responsible Party: Renée Shellhaas, MD, Clinical Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02789176     History of Changes
Other Study ID Numbers: HUM00114541
1507-31187 ( Other Identifier: PCORI project number )
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
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
Signs and Symptoms
Anticonvulsants