Dexmedetomidine for Analgosedation to Newborn Infants During Neonatal Intensive Care

NCT06482775 | Withdrawn DMC

• 1 other identifier: 2015-002506-37
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Intensive Care, Neonatal; Analgesia; Hypnotics and Sedatives

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline until 12 hours after stop of infusion

Secondary Outcomes (4)

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

  Baseline until 12 hours after stop of infusion

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

  Baseline until 12 hours after stop of infusion

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

  Once per second (from baseline until 12 hours after stop of infusion)

• Procedural pain response in relation to PK: assessed with change in galvanic skin response

  Once during treatment with dexmedetomidine

Study Arms (1)

dexmedetomidine

Infusion of dexmedetomidine 4 microgram/mL.

Drug: dexmedetomidine

Interventions

dexmedetomidine DRUG

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

dexmedetomidine

Eligibility Criteria

• Age: Up to 27 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Sick newborn infants in need of intensive care.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator
• Karolinska Institutet: collaborator
• Helsinki University Central Hospital: collaborator
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator
• Örebro University, Sweden: collaborator
• The Swedish Research Council: collaborator
• University of Tartu: collaborator
• University of Colorado, Denver: collaborator

Study Sites (2)

Skane University Hospital

Lund, 221 85, Sweden

Location

Karolinska Universitetssjukhuset

Stockholm, 171 76, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Elisabeth Norman, MD

  Region Skane

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: July 1, 2024
• Study Start: June 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2021
• Last Updated: July 1, 2024

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)