Dexmedetomidine for Analgosedation to Newborn Infants During Neonatal Intensive Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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

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Intensive Care, Neonatal Analgesia Hypnotics and Sedatives

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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dexmedetomidine

Infusion of dexmedetomidine 4 microgram/mL.

dexmedetomidine

Intervention Type DRUG

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

Interventions

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dexmedetomidine

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

Intervention Type DRUG

Eligibility Criteria

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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.

Maximum Eligible Age

27 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No