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Dexmedetomidine for Analgosedation to Newborn Infants During Neonatal Intensive Care | Clinical Trials | Clareo Health

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Dexmedetomidine for Analgosedation to Newborn Infants During Neonatal Intensive Care

Dexmedetomidine for Analgosedation to Newborn Infants During Neonatal Intensive Care - a Prospective Pharmacokinetic/ Pharmacodynamic/ Pharmacogenetic Observational Study.Cohort 3 in The SANNI Project.

NCT06482775•Region Skane

View on ClinicalTrials.gov

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

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

June 1, 2021

Primary Completion Date

December 1, 2021

Completion Date

December 31, 2021

Last Updated

July 1, 2024

Conditions

Intensive Care, NeonatalAnalgesiaHypnotics and Sedatives

Interventions

dexmedetomidine

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Dexmedetomidine for Analgosedation to Newborn Infants During Neonatal Intensive Care

Inclusion Criteria

Exclusion Criteria

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