Final Research Report

View this project's final research report.

Journal Citations

Article Highlight: Every year, about 16,000 newborns in the United States have seizures. Medications can treat seizures but can also have serious side effects and may harm children’s brain development. This PCORI-funded study compared functional development outcomes of 270 newborns who developed seizures due to acute brain injury in the first days to weeks after birth and were treated with antiseizure medication (ASM) prior to hospital discharge and those who continued ASM after hospital discharge. Reporting in JAMA Neurology, the study found that after two years, children in both groups did not differ significantly in their functional development and risk of epilepsy. These results support discontinuation of ASM prior to hospital discharge for most newborns with acute symptomatic neonatal seizures.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

  • The reviewers asked the researchers to clarify their process for balancing patient characteristics across the two treatment groups in order to test a causal hypothesis in this observational study.  The researchers calculated patient scores using participant characteristics that were associated with the chosen treatment approach, but the reviewers asked for assurances that the propensity score calculations were accurate, as this would affect the validity of the results. The researchers responded by describing several methods they used to calculate propensity score, all of which gave similar results. They also included a new table and figure showing how patient characteristics matched between the two treatment groups once propensity score adjustments were made.
  • The reviewers questioned why the researchers focused the second study aim on length of hospital stay instead of medication side effects or other clinical outcomes. The researchers explained that they were interested in assessing whether hospital discharge for the infant patients could happen sooner if antiseizure medications are withdrawn sooner. The researchers hoped that if they demonstrated shorter hospital stays related to medication discontinuation, they would encourage clinical teams to try to safely discontinue antiseizure medication sooner.
  • The reviewers challenged comments in the report linking phenobarbital use in infants to sedation and feeding problems as well as developmental delays, stating that some of these assertions have been challenged in the past. The researchers clarified their statements regarding sedation and feeding problems associated with any antiseizure medications, noting that their concerns specifically relate to prolonged phenobarbital use in infancy but not adequate dosage of phenobarbital to prevent seizures.

Conflict of Interest Disclosures

Project Information

Renée A. Shellhaas, MD, MS & Hannah C. Glass, MDCM, MAS
University of Michigan
$2,879,159
10.25302/07.2021.CER.150731187
Continued Anticonvulsants After Resolution of Neonatal Seizures: A Patient-Centered Comparative Effectiveness Study

Key Dates

April 2016
August 2021
2016
2021

Study Registration Information

Tags

Has Results
Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: April 26, 2022