Pilot Study of Bumetanide for Newborn Seizures
Completed · Phase 1 · Has a placebo group
Conditions studied: Seizures
In brief
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.
Key facts
- Study ID
- NCT00830531
- Run by
- Soul, Janet , M.D.
- People needed
- 43
- Starts
- 2010-01-01
- Expected to finish
- 2019-01-01
- Last updated by the study team
- 2020-12-17
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Tufts Floating Hospital for Children at Tufts Medical Center — Boston, Massachusetts, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Boston Children's Hospital — Boston, Massachusetts, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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