NCT06482775

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.

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 27 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Intensive Care, Neonatal
• Analgesia
• Hypnotics and Sedatives

Interventions

Type	Name	Description
DRUG	dexmedetomidine	The dosing and administration will be implemented according to an algorithm based on pain scoring results

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-12-01
• Completion: 2021-12-31
• First posted: 2024-07-01
• Last updated: 2024-07-01

Locations

2 sites across 1 country: Sweden