Continuing medication for newborns with seizures for months after they are discharged from the hospital does not prevent epilepsy and may cause neurotoxic side effects.
In a study led by UCSF Benioff Children’s Hospitals and University of Michigan C.S. Mott Children’s Hospital, researchers compared the outcomes of approximately 300 babies born in nine hospitals throughout the country. All newborns had developed seizures due to acute brain injury in the first few days to weeks after birth and were treated with phenobarbital and/or other anti-seizure medications.
Two-thirds of the infants continued treatment for an average of four months and the remainder stopped within a few days. However, no differences were found between the two groups in the number of children who were later diagnosed with epilepsy or in their developmental levels at 24 months, the researchers reported in their recent study in JAMA Neurology.
“This study supports the findings from smaller studies that stopping the anti-seizure medicine before a child goes home from the hospital leads to many fewer days of treatment with potentially harmful medications,” said first author Hannah Glass, MD, a pediatric neurologist at UCSF Benioff Children’s Hospitals, who is also affiliated with the UCSF Weill Institute for Neurosciences.
Neonatal seizures occur in more than 16,000 newborns each year in the United States and are usually precipitated by brain injuries at the time of birth. The seizures typically subside within three to four days, but nearly half of the newborns will have lifelong complications.
Many medical centers have favored longer-term use of medication, an approach that stems from the era before continuous video-EEG, MRI and genetic studies, which are now routinely used to determine the onset and resolution of seizures, as well as their causes, Glass noted.
“Both care providers and parents have wanted to evaluate the safety of stopping medications early, but a clinical trial could not be completed because of challenges enrolling families,” she said.
The researchers found that 13 percent of infants developed epilepsy – 11 percent in the short-term medication group and 14 percent in the long-term medication group – a difference that was not significant. Similarly, developmental scores ranked by the WIDEA-FS questionnaire were roughly the same for both groups.
“We really need to balance the risks of continuing medication with the benefits to babies’ health,” said senior author Renee Shellhaas, MD, pediatric neurologist at University of Michigan C.S. Mott Children’s Hospital. “If it’s not necessary, then keeping them on medicine could do more harm than good.”
The risk for remaining on phenobarbital, the drug received by 90 percent of the infants, is its potentially neurotoxic effects, which research indicates may be associated with lower cognitive scores over time. The drug is known to cause sedation in infants, making them less responsive to feeding and engaging with their world, activities that are important for growth and development.
“The results of this study will lead to a change in practice for many clinicians,” said Glass. “For infants who have seizures due to an early brain injury, and the treating physician has confirmed that the seizures have stopped for at least 24 hours of EEG monitoring, the medications can be safely discontinued.”
Glass together with Shellhaas and their colleagues will continue to follow this cohort to school age to assess their development, including their sensory processing and any learning disabilities, through research supported by the National Institutes of Health.