The PETITE research study will evaluate a study drug in controlling seizures in newborn babies. If you decide to participate in the PETITE study, your baby will receive the study drug for up to 96 hours. The duration depends on which treatment group your baby will be in. If your baby benefits from the study drug, the option of a longer treatment following the Evaluation Period will be offered. Otherwise, doses will be decreased over a period of up to 7 days to safely stop intake of the study drug. The decision how to proceed will be made together by the study doctor and you.
It is possible the study drug could reduce or stop your baby’s seizures, but there is no guarantee it will help. If your baby responds well to the treatment, you may have the option of keeping him or her on the study drug for a longer period including the option to participate in a follow-up study.
Please note if you decide to participate in the study, you are free to withdraw consent at any time and opt for another treatment option.
Before you decide whether to participate and consent to the study, the study doctor will discuss details with you, including possible side effects of the study drug, risks that may be associated with study procedures, and also answer all of your questions.
By participating in the PETITE study, you will help support an important health research project. Research is a crucial way to test and further develop new treatment options, which may improve the lives of newborns with seizures.
Study Progress Indicator
The PETITE Study is in the Enrolment Phase. This means, new patients can still enter the study since the target number of participants has not been achieved. First patients may have completed the study while others are still participating.
Download a Copy of the Quick Guide, containing Information about the Study