MedTrace Logo

Pilot Study of Bumetanide for Newborn Seizures

NCT00830531 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2020-12-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Bumetanide

Bumetanide either 0.1 mg/kg, 0.2 mg/kg or 0.3 mg/kg IV administered together with standard phenobarbital therapy

DRUG

Normal Saline as Placebo

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

Sponsors & Collaborators

  • Citizens United for Research in Epilepsy

    collaborator OTHER

  • Harvard Catalyst- Harvard Clinical and Translational Science Center

    collaborator UNKNOWN

  • Translational Research Program, Boston Children's Hospital

    collaborator UNKNOWN

  • Charles H. Hood Foundation

    collaborator OTHER

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Mooney Family Initiative for Translational Studies in Rare Diseases, Boston Children's Hospital

    collaborator UNKNOWN

  • Soul, Janet , M.D.

    lead INDIV

Principal Investigators

  • Janet Soul, MD,CM · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
44 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00830531 on ClinicalTrials.gov