Infants with induced hypothermic treatment after perinatal asphyxia
Conditions
Interventions
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Fetanyl
Other descriptive name: FENTANYL CITRATE
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
C
Sponsors
Skåne University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Term infants who, according to national guidelines, will receive hypothermic treatment following perinatal asphyxia, and are in need for analgesic or sedative medication according to clinical judgment based on Thomsons score and ALPS-Neo. •Existing arterial or venous cannulas/catheters for repeated non-traumatic blood sampling •Informed and written parental consent; Are the trial subjects under 18? yes Number of subjects for this age range: 50 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
Exclusion criteria: •AV- block I-III or HR < 70 – same as for hypothermia. •Serious CHD with need for postnatal surgery – same as for hypothermia •MABP <35 mmHg despite adequate treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The specific aims of this Project are to •study the PK of fentanyl and clonidine in infants receiving induced hypothermic treatment after perinatal asphyxia using NONMEM® (Non-linear Mixed Effect Modelling) population based PK modelling. • assess the effects of the drugs on brain function (PD) in these infants and relate the effects to drug concentration (PK/PD). ;Secondary Objective: • assess the effects of the drugs concentration (PK/PD) on to the physiological parameters (including NIRS) and the pain response (pain assessment scales and GSR) in these infants and relate the effects to drug concentration (PK/PD). • develop a Swedish version of COMFORT-neo that is valid and culturally adapted • validate ALPS-Neo against behavioural and biomedical pain markers (Comfort-neo, GSR and S-cortisol) • determine whether specific pharmacogenetic (PG) profile explains the PK and PD phenotypes of these drugs in newborn infants (PK/PD/PG). •collect descreptive data from neurological and cognitive follow-up examination at the age of 2 years . ;Primary end point(s): • Change in drug concentration (metabolism) related to body temperature • Effect of other medicines on clerance (including but not limited to phenobarbitone, midazolam, thiopentone). • Change in neurophysiology response in relation to PK ;Timepoint(s) of evaluation of this end point: Pre, during 72 h of hypothermic treatment until 72 h after normothermia is achieved. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Pre, during 72 h of hypothermic treatment until 72 h after normothermia is achieved. ;Secondary end point(s): •Change in/association between physiological parameters (heart rate (HR), mean arterial blood pressure (MABP, recorded invasively and, peripheral oxygen saturation (SpO2)) in relation to PK and other PD parameters. •Change in/association between pain responses as measured by pain assessment score for continuous pain/stress (ALPS-Neo and Comfort Neo) and GSR, in relation to PK and other PD. •Pain response as measured by pain assessment score ALPS-Neo and Comfort Neo in relation to GSR (=galvanic skin respons) •Change in S-Cortisol in relation to PK and PD and pain response at a standardized pain procedure performed at a stage of stability after 6 hours of unchanged medication, •How PK/PD phenotypes depend on pharmacogenetic (PG) profiles. | — |
Countries
Sweden
Contacts
Public ContactElisabeth Norman
Skåne University Hospital
Outcome results
None listed