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Continued anticonvulsants after resolution of neonatal seizures: a patient-centered comparative effectiveness study
Investigator (PI): Shellhaas, Renee
Performing Organization (PO): (Current): University of Michigan, Michigan Medicine, Department of Pediatrics, Division of Pediatric Neurology / (734) 936-4179
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2021
Record Source/Award ID: PCORI/CER-1507-31187
Funding: Total Award Amount: $2,876,265
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Seizures affect approximately 16,000 newborns a year in the United States. Neonatal seizures have lasting adverse impacts, not only for the affected children, but also for their families. Seizures in newborns carry a high mortality rate, and at least 50 percent of survivors have one or more long-term disability, such as cerebral palsy, intellectual disability, or epilepsy. For any major health condition, understanding the correct treatment choice and the ideal length of treatment is critical. Phenobarbital has been the mainstay of neonatal seizure treatment for decades, even though it has serious side effects. How long to treat a baby with seizures that are due to brain injury (also known as acute symptomatic neonatal seizures) with phenobarbital remains an open question and this uncertainty leads to significant practice variability. Animal models and observational studies of human infants raise concern that ongoing seizures harm the developing brain. Conversely, prolonged treatment with phenobarbital may have neurodevelopmental consequences. Clinicians, parents, professional organizations, and funding agencies all agree that this question must be answered. A well-conceived, large-scale observational study with a propensity score analysis strategy will allow causal inference to determine the optimal duration of medical treatment for neonatal seizures. The results will inform decision making regarding duration of treatment for acute symptomatic neonatal seizures. Our research team has established the Neonatal Seizure Registry, a multicenter association of children's hospitals across the United States. We partnered with a patient advocacy stakeholder organization and with multiple parent partners to develop a patient-centered study that is specifically designed to address the most pressing concerns of affected families. We will take advantage of heterogeneity of treatment duration for newborns in our registry to determine the comparative effectiveness of two common neonatal seizure treatment approaches--(1) short treatment duration (medication discontinued prior to discharge from hospital) and (2) prolonged treatment (medication continued until the time of outpatient follow-up)--on neurodevelopmental outcomes, rates of epilepsy, and parent/family well-being. Based on parent partner input, we will also examine whether inpatient treatment affects the length of initial hospital stay. We anticipate that the results of this research will lead to substantial changes in clinical care and stimulate meaningful improvements in outcomes for newborns with seizures. If giving more phenobarbital does not change the risk of developmental delay or epilepsy, and is acceptable to families, then this study will provide key evidence that shorter treatment duration is safe. In that case, a practice change to shorter treatment duration will eliminate unnecessary exposure to medication.
MeSH Terms:
  • Anticonvulsants /*therapeutic use
  • Cerebral Palsy /prevention & control
  • Comparative Effectiveness Research
  • * Drug Administration Schedule
  • Epilepsy /prevention & control
  • Hospitalization
  • Hospitals, Pediatric
  • Humans
  • Infant, Newborn
  • Intellectual Disability /prevention & control
  • Length of Stay
  • Multicenter Studies as Topic
  • Observational Studies as Topic
  • Patient-Centered Care
  • Phenobarbital /*administration & dosage
  • Registries
  • Risk
  • Seizures /*drug therapy
  • United States
Country: United States
State: Michigan
Zip Code: 48109
UI: 20163042
CTgovId: NCT02789176
Project Status: Ongoing