EHR Precision Drug Treatment in Neonates
Unknown statusNCT04850079
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Electronic Health Record (EHR)-Embedded Decision Support Platform for Individualized Precision Drug Treatment in Neonates
- Conditions
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Collaborators
- The Gerber Foundation
- Start date
- 2018-09-28
- Primary completion
- 2024-12
- Sex
- All
- Age range
- from 24 Weeks to 12 Months
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Age criteria: Corrected postmenstrual age ≥24 completed weeks 2. Treatment with IV morphine for \>24 hours per standard of care clinical pain management 3. Admitted to CCHMC NICU Exclusion Criteria: 1. Allergy to morphine 2. Confounding medical condition leading to therapy with other opiates 3. ECMO treatment 4. Concomitant medications that interfere with morphine metabolism/PK as determined by the PI
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04850079