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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04193839
Other study ID # NP 3751
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date June 1, 2021

Study information

Verified date December 2019
Source Fondazione Poliambulanza Istituto Ospedaliero
Contact Maria Pierro, MD, PhD
Phone +39030351
Email maria.pierro@poliambulanza.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date June 1, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Months
Eligibility Inclusion criteria:

- Admission to the NICU

- Need of pharmacological intervention

- Informed parental consent

Exclusion criteria:

- Lack of parental consent

Study Design


Related Conditions & MeSH terms

  • Adverse Drug Event
  • Drug-Related Side Effects and Adverse Reactions
  • Medication Errors and Other Product Use Errors and Issues

Intervention

Other:
Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA)
Computerized provider order entry (CPOE) refers to the process of providers entering and sending treatment instructions - including medication, laboratory, and radiology orders - via a computer application rather than paper, fax, or telephone. The bar Code Medication Administration (BCMA) is a system that consists of a bar code reader, a portable or desktop computer with wireless connection, a computer server, and some software. Before the administration of medications to the patients the patient unique barcode identification is scanned in order to verify the patient's identity.

Locations

Country Name City State
Italy Fondazione Poliambulanza Istituto Ospedaliero Brescia

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Poliambulanza Istituto Ospedaliero

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of medication errors The investigators will record all types of errors (prescription, transcription, preparation, administration errors) through spontaneous reporting, structured daily audit and chart revision From date of NICU admission up to discharge, up to 18 months
Secondary Number of preventable adverse drug events The investigators will record the number of preventable and non preventable adverse drug events From date of NICU admission up to discharge, up to 18 months
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