Plasma concentration dynamics of phenobarbital and lidocaine in neonates with seizures in hypothermia

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020103-70-EE

Enrollment

Registered

2011-12-29

Start date

2012-08-14

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal seizures

Interventions

Trade Name: LIDOCAINE-GRINDEKS Product Name: lidocaine Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: LIDOCAINE CAS Number: 137-58-6 Concentration unit: mg/ml milligram(s)/

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Gestational age > 36 week and postnatal age (PNA) =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: (1) Preceding treatment with phenytoin

Design outcomes

Primary

Measure	Time frame
Main Objective: -To describe PK profile of phenobarbital in term neonates with seizures in therapeutic hypothermia -To describe PK parameters of lidocaine in term neonates with seizures in therapeutic hypothermia ;Secondary Objective: To correlate plasma PK profiles of lidocaine and/or phenobarbital with clinical efficacy (cessation of clinical and/or subclinical seizures) in term neonates in therapeutic hypothermia -To assess the safety profiles of intravenous lidocaine and phenobarbital in term neonates with seizures in therapeutic hypothermia;Primary end point(s): Pharmacokinetics;Timepoint(s) of evaluation of this end point: For phenobarbital: beofore the infusion and after the end of the infusion (10 min after the initiation of the infusion) For lidocaine: 1)10 min, 2)1h 10 min, 3)6h 10 min, 4)7h 10 min, 5)18h 10 min, 6)19h 10 min 7)30h 10 min	—

Measure

Time frame

Main Objective: -To describe PK profile of phenobarbital in term neonates with seizures in therapeutic hypothermia -To describe PK parameters of lidocaine in term neonates with seizures in therapeutic hypothermia ;Secondary Objective: To correlate plasma PK profiles of lidocaine and/or phenobarbital with clinical efficacy (cessation of clinical and/or subclinical seizures) in term neonates in therapeutic hypothermia -To assess the safety profiles of intravenous lidocaine and phenobarbital in term neonates with seizures in therapeutic hypothermia;Primary end point(s): Pharmacokinetics;Timepoint(s) of evaluation of this end point: For phenobarbital: beofore the infusion and after the end of the infusion (10 min after the initiation of the infusion) For lidocaine: 1)10 min, 2)1h 10 min, 3)6h 10 min, 4)7h 10 min, 5)18h 10 min, 6)19h 10 min 7)30h 10 min

—

Secondary

Measure	Time frame
Secondary end point(s): - frequency of seizures - occurance of side-effects;Timepoint(s) of evaluation of this end point: - The occurence of seizures (seizure frequency)will be monitore by aEEG during hypothermia and during 7 days thereafter considering clinical syptoms - the occurence of side-effects will be monitored during the study and 7 days thereafter	—

Countries

Estonia

Contacts

Public ContactPediatric Intensive Care Unit

Tartu University Hospital

ltriin@ut.ee3727319553

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026