Clinical trial NCT02789176: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Seizures
Keywords: Phenobarbital
EEG
family impact
neurodevelopment
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Boston Children's Hospital
name: Children's Hospital of Philadelphia
name: Children's National Research Institute
name: Massachusetts General Hospital
name: Patient-Centered Outcomes Research Institute
name: Stanford University
name: Beth Israel Deaconess Medical Center
name: Brigham and Women's Hospital
name: Duke University
name: Children's Hospital Medical Center, Cincinnati
First posted: 2016-06-02
Enrollment: 303
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newborns with seizures who were admitted at one of the participating children's hospitals

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.


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

Primary outcomes:
measure: WIDEA Neurodevelopmental Outcome Score
timeFrame: 24 months
measure: Number of Participants With Post-neonatal Epilepsy
timeFrame: 24 months
Secondary outcomes:
measure: Length of Stay for the Neonatal Seizure Admission
timeFrame: length of stay, measured in days, will be recorded during a chart review when the child is 12 months of age
measure: Impact of Treatment Duration on Parent and Family Well-being
timeFrame: 24 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: University of Michigan
name: Renée A Shellhaas, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Hannah C Glass, MDCM, MAS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franck LS, Shellhaas RA, Lemmon M, Sturza J, Soul JS, Chang T, Wusthoff CJ, Chu CJ, Massey SL, Abend NS, Thomas C, Rogers EE, McCulloch CE, Grant K, Grossbauer L, Pawlowski K, Glass HC; Neonatal Seizure Registry study group. Associations between Infant and Parent Characteristics and Measures of Family Well-Being in Neonates with Seizures: A Cohort Study. J Pediatr. 2020 Jun;221:64-71.e4. doi: 10.1016/j.jpeds.2020.02.024.