neonatal convulsion
Conditions
Interventions
Sponsors
Kagawa University, University Hospital
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
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with abnormal movement suspected neonatal convulsion 2) Patients with asphyxia neonatorum (Apgar score of less than 5 at five minutes with a base deficit of more than 10 mmol/L) 3) Patients with traumatic delivery 4) Patients with central nerve system infection or malformation 5) Patients with abnormal movement by hypoglycemia or electrolyte abnormality
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| *Consistency of assessment between committee and investigator *Change in degree or frequency of convulsion 60 min. after administration | — |
Countries
Japan
Outcome results
None listed