EHR Precision Drug Treatment in Neonates

NCT04850079 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-06-18

No results posted yet for this study

Summary

This observational study is designed to evaluate the integration of a model-informed, clinically individualized pharmacokinetics (PK) profile (precision dosing dashboard) into prescribing clinicians' existing workflows to improve safety and efficacy of morphine dosing for neonates. The investigators will use user-centered participatory design methods and real-time analysis to inform the refinement of the recently developed Electronic Health Record (EHR) model-based decision support tool and test it during the pre-and post-implementation stages.

Conditions

  • Pain, Acute
  • Pain, Chronic

Sponsors & Collaborators

  • The Gerber Foundation

    collaborator OTHER
  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Alexander A Vinks, PharmD, PhD · Children's Hospital Medical Center, Cincinnati

Eligibility

Min Age
24 Weeks
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-28
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • United States

Study Locations

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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 NCT04850079 on ClinicalTrials.gov