Recommendations for the design of therapeutic trials for neonatal seizures.

ABSTRACT: Although seizures have a higher incidence in neonates than any other age group and are associated with significant mortality and neurodevelopmental disability, treatment is largely guided by physician preference and tradition, due to a lack of data from well-designed clinical trials. There is increasing interest in conducting trials of novel drugs to treat neonatal seizures, but the unique characteristics of this disorder and patient population require special consideration with regard to trial design. The Critical Path Institute formed a global working group of experts and key stakeholders from academia, the pharmaceutical industry, regulatory agencies, neonatal nurse associations, and patient advocacy groups to develop consensus recommendations for design of clinical trials to treat neon

SUBMITTER: Soul JS 

PROVIDER: S-EPMC6760680 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature