EHR Precision Drug Treatment in Neonates

NCT04850079 | Active Not Recruiting

• 1 other identifier: 2018-2806
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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' 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

Keywords

neonatal pain and sedation management

Outcome Measures

Primary Outcomes (3)

• Total morphine dose

  Comparison of pre-implementation compared with post-implementation amounts of morphine given,

  18 months

• As needed (pro re nata; PRN) medication

  Number of as needed (PRN) doses of morphine

  18 months

• Target concentration

  Cumulative amount of morphine exposure above target concentration

  18 months

Secondary Outcomes (1)

• Usability of the application

  18 months

Eligibility Criteria

• Age: 24 Weeks - 12 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

participants will be preterm and term neonates who receive intravenously (IV) administered morphine for 24 hours or more in the CCHMC NICU as part of standard clinical pain care management. Our target is a minimum of 200 evaluable research participants. All infants in the CCHMC NICU regardless of gender, race, or age are potential subjects. We anticipate that enrolled participants will be of mixed demographics. Newborns are considered vulnerable subjects. There will be no exclusions based on gender or ethnicity.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• The Gerber Foundation: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3026, United States

Location

Related Publications (1)

• Vinks AA, Punt NC, Menke F, Kirkendall E, Butler D, Duggan TJ, Cortezzo DE, Kiger S, Dietrich T, Spencer P, Keefer R, Setchell KDR, Zhao J, Euteneuer JC, Mizuno T, Dufendach KR. Electronic Health Record-Embedded Decision Support Platform for Morphine Precision Dosing in Neonates. Clin Pharmacol Ther. 2020 Jan;107(1):186-194. doi: 10.1002/cpt.1684. Epub 2019 Dec 11.

  PMID: 31618453 RESULT

Related Links

• Electronic Health Record-Embedded Decision Support Platform for Morphine Precision Dosing in Neonates

Biospecimen

Retention: SAMPLES WITHOUT DNA

The study will include the collection of discarded blood samples (remnant samples) from neonates who are already receiving morphine as part of their standard of care. This approach is successfully utilized in several 'POPS' studies (Pediatric Opportunistic Pharmacokinetic Studies as part of Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care program) conducted by the Pediatric Trials Network (http://pediatric trials.org/).

MeSH Terms

Conditions

Acute Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander A Vinks, PharmD, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 20, 2021
• Study Start: September 28, 2018
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)