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Dexmedetomidine for Analgosedation to Newborn Infants During Neonatal Intensive Care

NCT06482775 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2024-07-01

No results posted yet for this study

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

Interventions

DRUG

dexmedetomidine

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

Sponsors & Collaborators

  • Lund University

    collaborator OTHER

  • Karolinska Institutet

    collaborator OTHER

  • Helsinki University Central Hospital

    collaborator OTHER

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    collaborator OTHER

  • Örebro University, Sweden

    collaborator OTHER

  • The Swedish Research Council

    collaborator OTHER_GOV

  • University of Tartu

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • Region Skane

    lead OTHER

Principal Investigators

  • Elisabeth Norman, MD · Region Skane

Eligibility

Max Age
27 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2021-12-01
Completion
2021-12-31

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06482775 on ClinicalTrials.gov