Clinical trial NCT06482775: Dexmedetomidine for Analgosedation to Newborn Infants During Neonatal Intensive Care
Official title: Dexmedetomidine for Analgosedation to Newborn Infants During Neonatal Intensive Care - a Prospective Pharmacokinetic/ Pharmacodynamic/ Pharmacogenetic Observational Study.Cohort 3 in The SANNI Project.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Intensive Care, Neonatal
Analgesia
Hypnotics and Sedatives
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
name: Karolinska Institutet
name: Helsinki University Central Hospital
name: Great Ormond Street Hospital for Children NHS Foundation Trust
name: Örebro University, Sweden
name: The Swedish Research Council
name: University of Tartu
name: University of Colorado, Denver
First posted: 2024-07-01
Enrollment: 0
Sex: ALL
Maximum age (years): 27
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sick newborn infants in need of intensive care.

Brief summary: 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.

Detailed description: 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.

Eligibility 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 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.

Primary outcomes:
measure: Pharmacokinetics (PK) of dexmedetomidine
timeFrame: Repeated blood samples (5 minutes after the loading dose until 12 hours after stop of infusion)
measure: Neurophysiologic response; global brain network function in relation to PK
timeFrame: Baseline until 12 hours after stop of infusion
Secondary outcomes:
measure: Change in heart rate, HR, (hemodynamic response) in relation to PK (PK/PD)
timeFrame: Baseline until 12 hours after stop of infusion
measure: Change in mean arterial blood pressure, MABP, (hemodynamic response) in relation to PK (PK/PD)
timeFrame: Baseline until 12 hours after stop of infusion
measure: Change in/association between Near Infrared spectroscopy, NIRS, in relation to PK.
timeFrame: Once per second (from baseline until 12 hours after stop of infusion)
measure: Procedural pain response in relation to PK: assessed with change in galvanic skin response
timeFrame: Once during treatment with dexmedetomidine
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skane University Hospital
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
Study officials:
affiliation: Region Skane
name: Elisabeth Norman, MD
role: PRINCIPAL_INVESTIGATOR
References: