Status:
ACTIVE_NOT_RECRUITING
EHR Precision Drug Treatment in Neonates
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
The Gerber Foundation
Conditions:
Pain, Acute
Pain, Chronic
Eligibility:
All Genders
24-12 years
Brief 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' ...
Detailed Description
Aim 1: To successfully implement a morphine PK and individualized precision dosing decision aid into workflows of neonatal prescribing clinicians. This study will evaluate the steps required to succe...
Eligibility Criteria
Inclusion
- Age criteria: Corrected postmenstrual age ≥24 completed weeks
- Treatment with IV morphine for \>24 hours per standard of care clinical pain management
- Admitted to CCHMC NICU
Exclusion
- Allergy to morphine
- Confounding medical condition leading to therapy with other opiates
- ECMO treatment
- Concomitant medications that interfere with morphine metabolism/PK as determined by the PI
Key Trial Info
Start Date :
September 28 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04850079
Start Date
September 28 2018
End Date
December 1 2024
Last Update
June 18 2024
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3026