PHARMACOLOGY STUDY FOR EFFICACY OF TOPIRAMATE ASSOCIATED WITH HYPOTHERIMIA TREATMENT IN NEWBORNS WITH HYPOXIC ISCHEMIC ENCEPHALOPATY: A PILOT STUDY - HYPOTHERMIA AND TOPIRAMATE
- Conditions
- POST-ASPHYCTIC ENCEPHALOPATHYMedDRA version: 9.1Level: SOCClassification code 10029205
- Registration Number
- EUCTR2010-018627-25-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA MEYER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
MODERATE-SEVERE ASPHYXIA IN TERM NEWBORNS
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
CONGENITAL ABNORMALITIES (CEREBRAL MALFORMATIONS)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: TO EVALUATE THE POSSIBLE NEUROPROTECTIVE ADDITIVE EFFECT BETWEEN HYPOTHERMIA TREATMENT COMBINATED WITH ORAL TOPIRAMATE ADMINISTRATION: REDUCTION OF MORTALITY AND SEVERE NEUROLOGIC DISABILITY;Secondary Objective: PSYCHOMOTOR EVALUATION AT 18 MONTHS MULTIPLE DISABILITY;Primary end point(s): MORTALITY AND NEURODEVELOPMENT SCORE AT 18 MONTHS OF LIFE
- Secondary Outcome Measures
Name Time Method