Pilot Study of Bumetanide for Newborn Seizures (NCT00830531) | Clinical Trial Compass
CompletedPhase 1
Pilot Study of Bumetanide for Newborn Seizures
United States43 participantsStarted 2010-01
Plain-language 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.
Who can participate
Age range
44 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary outcome is determination of the pharmacokinetics and safety of bumetanide in newborns with refractory seizures.
Timeframe: 6-7 years are anticipated for the collection of the neonatal data