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Clonidine for Analgesia to Preterm Infants During Neonatal Intensive Care

NCT04928651 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2023-08-04

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, in clonidine administered for analgesia and sedation to preterm newborn infants receiving neonatal intensive care. Phase 3 - therapeutic confirmatory study

Conditions

  • Intensive Care, Neonatal
  • Analgesia
  • Hypnotics and Sedatives

Interventions

DRUG

Clonidine

Clonidine will be administered to preterm infants in need of analgesia and sedation; either as the primary drug for comfort and light sedation or as an "add-on" drug to opioids according to an algorithm based on pain and sedative scoring results. Opioids are mostly given to postoperative patients. These drugs (morphine or fentanyl) will not be studied, but a baseline PK sample will be taken to correlate to the baseline aEEG.

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
37 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-06
Primary Completion
2022-05-13
Completion
2022-05-13

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 NCT04928651 on ClinicalTrials.gov