Pilot Study of Bumetanide for Newborn Seizures

• Status: Completed
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The main goal of the study is to obtain pharmacokinetic and safety data of bumetanide in newborns with refractory seizures. The overall hypothesis is that bumetanide, added to conventional antiepileptic (antiseizure) medications, will be a safe and well tolerated medication, compared with conventional antiepileptic drugs alone.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Soul, Janet , M.D.
• Collaborators: Charles H. Hood Foundation; Citizens United for Research in Epilepsy; Harvard Catalyst- Harvard Clinical and Translational Science Center; Mooney Family Initiative for Translational Studies in Rare Diseases, Boston Children's Hospital; National Institute of Neurological Disorders and Stroke (NINDS); Translational Research Program, Boston Children's Hospital
• Treatments: Bumetanide; Phenobarbital

Criteria

Inclusion Criteria:

• newborns with a post-conceptional age of 33-44 weeks

• condition with risk for seizure:

• asphyxia

• intracranial hemorrhage

• suspected or confirmed stroke

• CNS infection

• genetic syndrome

• focal or diffuse brain malformation

• idiopathic or presumed genetic etiology of seizures

• metabolic disorder other than electrolyte disturbances or those caused by renal failure

• suspected clinical seizure

Exclusion Criteria:

• have transient metabolic abnormalities (e.g., transient hypocalcemia) as the sole cause of seizures

• are receiving ECMO (extracorporeal membrane oxygenation) therapy because of alteration of bumetanide pharmacokinetics by ECMO

• have contraindications to bumetanide (as determined by treating physician)

• have received diuretics such as furosemide or BTN

• newborns with a total serum bilirubin > 15 mg/dL at enrollment

• newborns given ≥ 40mg/kg of phenobarbital

• loading doses of AEDs other than phenobarbital (those who receive levetiracetam are still eligible since levetiracetam does not affect bumetanide pharmacokinetics)