Trial · NCT00830531
Pilot Study of Bumetanide for Newborn Seizures
NCT00830531, Phase 1, Completed, Soul, Janet , M.D.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pilot Study of Bumetanide for Newborn Seizures. Trials, record NCT00830531. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00830531
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study of Bumetanide for Newborn Seizures
- NCT number
- NCT00830531
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 43 participants, actual
- Lead sponsor
- Soul, Janet , M.D.
- Conditions
- Seizures
- Interventions
- Bumetanide, Normal Saline as Placebo
- First posted
- 2009-01-28
- Last updated
- 2020-12-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The primary outcome is determination of the pharmacokinetics and safety of bumetanide in newborns with refractory seizures. | 6-7 years are anticipated for the collection of the neonatal data | 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. |
| Secondary | A secondary outcome is determination of the feasibility of the study design to test antiepileptic drugs to treat neonatal seizures caused by acute hypoxic-ischemic encephalopathy in a clinical trial. | 6-7 years are anticipated for collection of the neonatal data | The investigators will determine the feasibility of enrolling and randomizing newborns early in the course of their refractory seizures. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01NS066929 | Pilot Trial of Bumetanide for Neonatal Seizures | SOUL, JANET SUSAN | BOSTON CHILDREN'S HOSPITAL | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2010 to 2014 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00830531
GET https://conductscience.org/api/trials/v1/NCT00830531/registered