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Clinical Trials/NCT04193839
NCT04193839
Unknown
N/A

Reducing Errors In The Neonatal Intensive Care Unit. The SAPHET-i Study: Secure, Automated, Functional, High-Tech Therapeutic Approach for iNFANTS

Fondazione Poliambulanza Istituto Ospedaliero1 site in 1 country100 target enrollmentJanuary 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Medication Errors and Other Product Use Errors and Issues
Sponsor
Fondazione Poliambulanza Istituto Ospedaliero
Enrollment
100
Locations
1
Primary Endpoint
Number of medication errors
Last Updated
6 years ago

Overview

Brief Summary

This is a monocentric prospective pre and post-intervention study, aiming at analyzing the efficacy of the Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA) as compared to paper order entry in reducing medication erros (MEs) in the Neonatal Intensive Care Unit (NICU)

Detailed Description

Medication errors are a burden to the health care system. The neonatal population, in particular the infants admitted to the NICU, are at higher risk of MEs as compared to the adult and pediatric population. Moreover adverse events (ADEs) occur more frequently and may be particularly severe in neonates. Several strategies have been tried in order to decrease the incidence of MEs in the NICU. Among these, some studies investigated the effectiveness of CPOE in reducing MEs in hospitalised patients. However, results have been inconsistent. So far, no study investigated the association of CPOE + BCMA in neonates. The investigators designed a monocentric prospective pre and post-intervention observational study to investigate the efficacy of the CPOE plus BCMA as compared to paper order entry in reducing MEs in the NICU population.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
June 1, 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Fondazione Poliambulanza Istituto Ospedaliero
Responsible Party
Principal Investigator
Principal Investigator

Maria Pierro

Principal investigator

Fondazione Poliambulanza Istituto Ospedaliero

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Number of medication errors

Time Frame: From date of NICU admission up to discharge, up to 18 months

The investigators will record all types of errors (prescription, transcription, preparation, administration errors) through spontaneous reporting, structured daily audit and chart revision

Secondary Outcomes

  • Number of preventable adverse drug events(From date of NICU admission up to discharge, up to 18 months)

Study Sites (1)

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