Plasma concentration dynamics of phenobarbital and lidocaine in neonates with seizures in hypothermia
- Conditions
- eonatal seizuresTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2010-020103-70-EE
- Lead Sponsor
- niversity of Tartu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
1) Gestational age > 36 week and postnatal age (PNA) <6 hours
(2) Need for therapeutic hypothermia according to criteria of the International Liaison Committee on Resuscitation (ILCOR) (Hoehn et al., 2008)
(3) Clinical need for an arterial or central venous catheter
(4) Admission to 3rd level neonatal intensive care unit
(5) Informed consent by the parents or by the legitimate representative of the child
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
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
(1) Preceding treatment with phenytoin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method