EUCTR2010-020103-70-EE
Active, not recruiting
Not Applicable
Pharmacokinetics of intravenous phenobarbital and lidocaine in the treatment of neonatal seizures of term neonates requireing therapeutic hypothermia - Pharmacokinetics of phenobarbital and lidocaine in neonates in hypothermia
niversity of Tartu0 sites20 target enrollmentStarted: December 29, 2011Last updated:
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- niversity of Tartu
- Enrollment
- 20
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Exclusion Criteria
- •(1\) Preceding treatment with phenytoin
Investigators
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