An observational study in Asphyxia Neonatorum, sponsored by Region Skane. Completed at 2 sites in Sweden. Open to participants aged 36 Weeks and older. Per ClinicalTrials.gov, last updated 2021-06-09.
Sponsored by Region Skane · Observational
A prospective pharmacokinetic (PK), pharmacodynamic (PD) and pharmacogenetic (PG) observation study, including the PK/PD/PG relationship, in fentanyl and clonidine administered for analgesia and sedation to term newborn asphyxiated infants receiving hypothermic treatment in the NICU.
All patients that are admitted to the study neonatal intensive care units (NICUs) for hypothermic treatment due to perinatal asphyxia are potential study patients, and their parents will be asked for consent.
The patient will be treated according to clinical guidelines and will be included in the study if in need for fentanyl and clonidine according to clinical judgment (HIE and pain scores) and as decided by the responsible clinical doctor. The dosing and administration of the drugs will be implemented according to an algorithm based on pain scoring results.
Apart from extra blood sampling, the bedside monitoring, investigations (electroencephalography (EEG), echocardiography (ECG), ultrasound of the brain and magnetic resonance imaging, (MRI)) and follow-up (neurologic examination) are the same as for all infants receiving hypothermia according to national and international guidelines. A brief standardised pain stimulation will be performed as part of the pain and stress assessment.
In total 50 infants will be included.
Term asphyxiated infants admitted to the NICU for hypothermic treatment according to national and international guidelines and in need for analgesia according to pain assessment scales.
Exclusion Criteria:
All infants in need of analgesia according to an algorithm based on pain assessment results will receive fentanyl as the first analgesic drug.
Drug: Fentanyl
Infants in need of further analgesia according to an algorithm based on pain assessment results will receive fentanyl and clonidine as the analgesic drugs.
Drug: Fentanyl and clonidine
The dosing and administration of fentanyl will serve as the first drug intervention in infants in need of analgesia according to an algorithm based on pain scoring results.
In infants in need of further analgesia clonidine will be administered as an add on drug according to an algorithm based on pain scoring results.
Pharmacokinetics (PK) of fentanyl and clonidine
Analysed with NONMEM (Non-linear Mixed Effect Modelling) populationbased PK statistics
Time frame: Repeated blood samples over a total of 4 - 7 days]
Neurophysiologic response; by single cortical events and their dynamics in relation to PK
Analyse of single cortical events and their dynamics based on burst detection and measuring features of individual bursts as well as their mass statistical behaviour over time.
Time frame: From admission to the department until 4- 72 h after reaching normothermia.]
Neurophysiologic response; longer term brain function in relation to PK
Assessment of longer term brain function using measures of long range correlation and brain activity cycling.
Time frame: From admission to the department until 4- 72 h after reaching normothermia
Neurophysiologic response; global brain network function in relation to PK
Assessment of global brain network function will be based on Activation Synchrony Index.
Time frame: From admission to the department until 4- 72 h after reaching normothermia
Change in/association between physiological parameters (heart rate, blood pressure, peripheral oxygen saturation and NIRS (near-infrared reflectance spectroscopy near-infrared spectroscopy) parameters) in relation to PK parameters
Time frame: From admission to the department until 4- 72 h after reaching normothermia.
Change in pain responses as measured by pain assessment score for continuous pain/stress (ALPS-Neo and Comfort Neo) in relation to PK
Time frame: From admission to the department until 4- 72 h after reaching normothermia.
Procedural pain response at a short standardized pain stimulation; as assessed with change in galvanic skin response, change in serum-cortisol and scored by a procedural pain assessment scale (PIPP-R) in relation to PK.
Time frame: Once during stable treatment with hypothermia and 6 hours of unchanged medication
Pharmacogenetic profile in relation to PK and PD results; how PK/PD phenotypes depend on pharmacogenetic (PG) profiles.
Time frame: One blood sample during study
Plan to share: No
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Region Skane