Sick newborn infants in need of intensive care.
Conditions
Interventions
Trade Name: Dexmedetomidine Teva
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: DEXMEDETOMIDINE
CAS Number: 113775-47-6
Concentration unit: µg/ml microgram(s)/millilitre
Concentration
Sponsors
Region Skane
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Newborn infants - born 34+0 gw with a need for dexmedetomidine for analgesic and/or sedative treatment after postnatal surgical correction of congenital malformations and who will be cared for in the PICU/postoperative unit and in a some few cases in the NICU, or - with a corresponding age of 37 gw, who are in need for dexmedetomidine according to clinical judgment (scoring with pain assessment scales; ALPS-Neo and Comfort-Neo) and cared for in the NICU. • Existing arterial or venous cannulas/catheters for repeated nontraumatic blood sampling • Informed and written parental consent obtained before study start. Are the trial subjects under 18? yes Number of subjects for this age range: 100 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: •Infant older than age corresponding to gw 46+0 •Previous treatment with the dexmedetomidine or clonidine within 72 hours (only for postoperative infants). •Congenital cardiac malformations requiring surgery on extracorporeal circulation and treatment with hypothermia. •Ongoing renal replacement treatment •Any serious medical condition or ethical issues that could, in the investigators opinion, interfere with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • study the PK of dexmedetomidine using NONMEM® (Non-linear Mixed Effect Modelling) population-based PK modelling (62) and • assess the effects of the drug on brain function (PD) and relate the effects to drug concentration (PK/PD).;Secondary Objective: • the physiological parameters (including NIRS), • 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), and • determine whether a specific pharmacogenetic (PG) profile explains the PK and PD phenotypes of this drugs in newborn infants (PK/PD/PG).;Primary end point(s): 1. Pharmacokinetics (PK) of dexmedetomidine 2. Change in hemodynamic response in relation to PK (PK/PD) 3. Change in neurophysiology response in relation to PK (PK/PD);Timepoint(s) of evaluation of this end point: From 30 min before start of study medication until 24 hours after stop of study medicaton. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 PDs. •Pain response as measured by pain assessment score ALPS-Neo and Comfort Neo in relation to GSR. •Procedural pain response, as scored by PIPP-R, to a standardized pain provocation. •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.;Timepoint(s) of evaluation of this end point: From 30 min before start of study medication until 24 hours after stop of study medicaton. Procedural pain response and change in s-kortisol is only measured once during the study. | — |
Countries
Sweden
Contacts
Public ContactElisabeth Norman
Skane University Hospital
Outcome results
None listed