A phase III, efficacy and safety study of phenobarbital sodium injection in newborns with neonatal convulsio
Phase 3
- Conditions
- neonatal convulsion
- Registration Number
- JPRN-C000000410
- Lead Sponsor
- Kagawa University, University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with hypersensitivity to Phenobarbital or Barbituric compounds 2) Patients with acute intermittent porphyria 3) Patients after anticonvulsant or Barbituric preparation therapy 4) Patients with any trauma except birth injury 5) Patients with therapeutic hypothermia of brain 6) Patients participated to other clinical trials 7) Patients judged as inappropriate to participate in this study by investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of "excellent" cases Excellent : disapperance of convulsion Effective : improvement of degree or frequency of symptom Poor : no improvement Change in degree or frequency of convulsion 30 min. after administration
- Secondary Outcome Measures
Name Time Method *Consistency of assessment between committee and investigator *Change in degree or frequency of convulsion 60 min. after administration