Pilot Study of Bumetanide for Newborn Seizures: A Phase I Study of Pharmacokinetics and Safety of Bumetanide for Neonatal Seizures
Description of Study
This is a multicentre (Children’s, BWH and MGH and Tufts MC), randomized, double blind trial of Bumetanide for the treatment of refractory neonatal seizures. This pilot trial is designed to look at the safety and pharmacodynamics of Bumetanide in the term newborns with hypoxic-ischemic encephalopathy, focal or multi-focal stroke, or intracranial hemorrhage.
Inclusion Criteria
- Term newborns with a postconceptional age of 33-44 weeks who present with seizures or are at risk of developing seizures.
Exclusion Criteria
- Suspected or confirmed brain malformation, chromosomal anomaly or genetic syndrome, congenital (in utero) infection, meningitis, encephalitis or sepsis, metabolic abnormalities (e.g., transient hypocalcemia as the sole cause of seizures), or inborn error of metabolism.
- Newborns who have received diuretics such as furosemide
- Any newborn with a total serum bilirubin > 15 mg/dL
- Newborns who have already received multiple anti seizure medications prior to enrollment.
Expected number of eligible newborns in MGH
We would expect to enroll 8-10 infants/year at MGH.
Aims
- To determine the feasibility of a novel study design to test antiepileptic drugs to treat neonatal seizures caused by acute hypoxic-ischemic encephalopathy, focal or multi-focal stroke, or intracranial hemorrhage in a clinical trial.
- To determine the pharmacokinetics of bumetanide in term newborns with seizures caused by acute hypoxic-ischemic encephalopathy, focal or multi-focal stroke, or intracranial hemorrhage.
- To determine the safety of a single dose of bumetanide in term newborns with refractory seizures caused by acute hypoxic-ischemic encephalopathy, focal or multi-focal stroke, or intracranial hemorrhage.
