A phase III, efficacy and safety study of phenobarbital sodium injection in newborns with neonatal convulsion

UMIN ID: C000000410

Registered date:26/04/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: neonatal convulsion
• Date of first enrollment: 2005/11/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): phenobarbital sodium injection

Outcome(s)

• Primary Outcome: 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: *Consistency of assessment between committee and investigator *Change in degree or frequency of convulsion 60 min. after administration

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 4weeks-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Kagawa University, University Hospital
• Secondary Sponsor: Osaka MCRI for MCH,Kanagawa CMC,Kumamoto Municipal Hospital of Kumamoto City,NCCHD,Showa University Hospital,The University of Tokyo Hospital,NHO Okayama Medical Center
• Source(s) of Monetary Support: Japan Medical Association