Results Summary

What was the research about?

Every year, about 16,000 newborns in the United States have seizures. A seizure is abnormal electrical activity in the brain. At least half of newborns who have seizures will have long-term health problems, such as epilepsy or an intellectual disability.

Medicines can treat seizures. But these medicines can have serious side effects and may harm children’s brain development. Questions remain about how long newborns can safely take these medicines.

In this study, the research team wanted to learn if stopping seizure medicines before newborns went home from the hospital would affect their health and their parents’ well-being. The team compared newborns who took medicines only in the hospital versus those who continued the medicines after they went home.

What were the results?

Of newborns in the study, 36 percent took medicines only in the hospital, and 64 percent took medicines in the hospital and at home. Among newborns who took medicines at home,

  • 68 percent took phenobarbital
  • 13 percent took levetiracetam
  • 20 percent took more than one medicine

After two years, the two groups didn’t differ in

  • Functional development, which included physical abilities, communication, skills like feeding and dressing, and social awareness
  • Motor disability, or how well children could walk without stumbling or falling
  • The risk of developing epilepsy
  • Time newborns spent in the hospital

Further analyses by the research team found differences in parents’ well-being between the two groups. Parents of newborns who took medicines only in the hospital reported a lower impact of illness on the family. But they reported worse anxiety, depression, and resilience.

Who was in the study?

The study included 270 children who received care at nine hospitals across the United States. Of these, 63 percent were White, 12 percent were Black, 7 percent were Asian, 3 percent were more than one race, and 15 percent didn’t report a race; 54 percent were boys.

What did the research team do?

The research team enrolled children who were treated for seizures in the hospital as newborns and their parents. Doctors had worked with parents to choose if newborns took seizure medicines only in the hospital or also at home.

Parents completed surveys when children were 12, 18, and 24 months old. The research team reviewed health records to collect data about the newborns’ health and hospital stays.

Parents of newborns who had seizures and people from advocacy groups helped design and carry out the study.

What were the limits of the study?

The study looked at children’s health for two years; health differences could appear when children are older. Fewer infants developed epilepsy than expected, which made it hard to find differences in the risk of developing the illness.

Future research could follow children who had treatment for seizures as newborns for a longer time.

How can people use the results?

Doctors and parents can use these results when considering how to treat newborns with seizures.

More About This Research

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

View the COI disclosure form.

Project Information

Renée A. Shellhaas, MD, MS & Hannah C. Glass, MDCM, MAS
University of Michigan
$2,879,159
10.25302/07.2021.CER.150731187

Key Dates

58 months
April 2016
August 2021
2016
2021

Study Registration Information

Tags

Has Results
Project Status
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
Funding Opportunity Type
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
Research Priority Area
State

State

The state where the project originates, or where the primary institution or organization is located.

View Glossary
Last updated: October 20, 2021