Study (population) pharmacokinetics of midazolam, morphine, phenobarbital and lidocaïne during therapeutic hypothermia for adequate dose adjustments.
ID
Source
Brief title
Condition
- Encephalopathies
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PK-population profiles of midazolam, morphine, phenobarbitone and lidocaine.
Secondary outcome
Not applicable
Background summary
Therapeutic hypothermia is a relatively new therapy for acute perinatal
asphyxia followed by neonatal encephalopathy. Therapeutic hypothermia is known
to alter PK -parameters. Moreover, (asphyxiated) neonates have immature enzyme
systems and impaired renal/hepatic function. The effect of drugs is
unpredictable. Thus, TDM is essential to prevent toxicity or subtherapeutic
therapy.
Study objective
Study (population) pharmacokinetics of midazolam, morphine, phenobarbital and
lidocaïne during therapeutic hypothermia for adequate dose adjustments.
Study design
observational design with invasive measure
Study burden and risks
During 4 following days 1 mL of arterial blood is withdrawn from an arterial
line, concurrently with morning blood withdrawal for clinical chemical
analysis. There will be no extra punction. Blood will be analyzed once a day.
Dose adjustments can be made if required (due to result of blood analysis).
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
Gestation >= 36 weeks;AND
- Perinatal asphyxia with Apgar 5 min <= 5 OR
- Resuscitation/ventilation during 10 minutes after birth OR
- pH < 7 and base-deficit > 16 mmol/L (cord blood or within 1 hour after birth in arterial or venous blood) OR
- lactate > 10 mmol/L L (cord blood or within 1 hour after birth in arterial or venous blood);AND encephalopathy (Thomson score > 7 after 1 and 3 hours after birth)
Exclusion criteria
Infants expected to be > 6 hours of age at the time of starting cooling
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26682.041.09 |