Dexmedetomidine for Analgosedation to Newborn Infants During Neonatal Intensive Care

Region Skane

Overview

A prospective pharmacokinetic (PK), pharmacodynamic (PD) and pharmacogenetic (PG) observation study, including the PK/PD/PG relationship, on dexmedetomidine administered for analgesia and sedation to postsurgical and other newborn sick infants needing the drug for clinical reasons during neonatal intensive care. Phase III - therapeutic confirmatory study.

The patients will be treated according to clinical guidelines and judgement as decided by the responsible clinical doctor. The dosing and administration of dexmedetomidine will be implemented according to an algorithm based on pain scoring results. Apart from extra blood sampling and extended bedside monitoring for amplitude-integrated EEG (aEEG), Near InfraRed Spectroscopy (NIRS), and Galvanic Skin Response (GSR) the care is according to clinical routine. In total 100 infants will be included.

Study Type

OBSERVATIONAL

Conditions

Intensive Care, Neonatal Analgesia Hypnotics and Sedatives

Interventions

dexmedetomidineDRUG

The dosing and administration will be implemented according to an algorithm based on pain scoring results

Eligibility

Sex: ALLMax age: 27 Days

Medical Language ↔ Plain English

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 intensive care unit) and in a some few cases in the NICU (neonatal intensive care unit), or * with a corresponding age of 37 gw, who are in need for dexmedetomidine according to clinical judgment 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. Exclusion Criteria: * Infant older than age corresponding to gw 46+0 * Previous treatment with the dexmedetomidine 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.

Locations (2)

Skane University Hospital

Lund, Sweden

Karolinska Universitetssjukhuset

Stockholm, Sweden

Outcomes

Primary Outcomes

Pharmacokinetics (PK) of dexmedetomidine

The plasma concentration will be analysed and then further reported using NONMEM® (Non-linear Mixed Effect Modelling) population-based PK modelling.

Time frame: Repeated blood samples (5 minutes after the loading dose until 12 hours after stop of infusion)

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: Baseline until 12 hours after stop of infusion

Secondary Outcomes

Change in heart rate, HR, (hemodynamic response) in relation to PK (PK/PD)

HR will be monitored 1/second according to clinical routine in the neonatal intensive care, and concomitantly downloaded into the aEEG (amplitude integrated electroencephalography) monitor. The change will be described as percentage increase/decrease. The change from baseline response in heart rate using longitudinal models of data on these endpoints following dexmedetomidine administration using a population PK/PD approach.

Time frame: Baseline until 12 hours after stop of infusion

Change in mean arterial blood pressure, MABP, (hemodynamic response) in relation to PK (PK/PD)

MABP will be monitored 1/second according to clinical routine in the neonatal intensive care, and concomitantly downloaded into the aEEG (amplitude integrated electroencephalography) monitor. The change will be described as percentage increase/decrease. The change from baseline response in MABP using longitudinal models of data on these endpoints following dexmedetomidine administration using a population PK/PD approach.

Time frame: Baseline until 12 hours after stop of infusion

Change in/association between Near Infrared spectroscopy, NIRS, in relation to PK.

NIRS will be monitored 1/second according to clinical routine in the neonatal intensive care, and concomitantly downloaded into the aEEG (amplitude integrated electroencephalography) monitor. The change will be described as percentage increase/decrease

Data from ClinicalTrials.gov

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