Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00830531 | Pilot Study of Bumetanide for Newborn Seizures | PHASE1 | COMPLETED | 43 | — | — | Jan 1, 2010 | Jan 1, 2019 | Dec 17, 2020 | 4 | United States |
The investigators will determine the dose exposure, half-life, volume of distribution and clearance of bumetanide in newborns with refractory seizures. The investigators will determine if there is a significant effect of hepatic dysfunction or hypothermia on bumetanide pharmacokinetics. For evaluation of safety, the rate of adverse events will be compared between treatment and control groups.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Standard phenobarbital combined with either 0.1 mg/kg, 0.2 mg/kg, or 0.3 mg/kg of bumetanide as determined by the status of the dose escalation design. |
| 2 | PLACEBO_COMPARATOR | Standard phenobarbital therapy combined with normal saline as placebo for bumetanide |
| Name | Type | Description |
|---|---|---|
| Bumetanide | DRUG | Bumetanide either 0.1 mg/kg, 0.2 mg/kg or 0.3 mg/kg IV administered together with standard phenobarbital therapy |
| Normal Saline as Placebo | DRUG | Normal Saline as placebo for bumetanide either 0.1 mg/kg, 0.2 mg/kg or 0.3 mg/kg IV administered together with standard phenobarbital therapy |
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...