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Reducing Errors In The Neonatal Intensive Care Unit

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04193839
Acronym
SAPHET-i
Enrollment
100
Registered
2019-12-10
Start date
2020-01-01
Completion date
2021-06-01
Last updated
2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Drug Event, Medication Errors and Other Product Use Errors and Issues

Keywords

Computerized Provider Order entry, Patient safety, Quality improvement, Medication errors, Adverse events, Bar code medication administration, Neonates

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.

Interventions

OTHERComputerized 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.

Sponsors

Fondazione Poliambulanza Istituto Ospedaliero
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No

Inclusion criteria

* Admission to the NICU * Need of pharmacological intervention * Informed parental consent

Exclusion criteria

* Lack of parental consent

Design outcomes

Primary

MeasureTime frameDescription
Number of medication errorsFrom date of NICU admission up to discharge, up to 18 monthsThe investigators will record all types of errors (prescription, transcription, preparation, administration errors) through spontaneous reporting, structured daily audit and chart revision

Secondary

MeasureTime frameDescription
Number of preventable adverse drug eventsFrom date of NICU admission up to discharge, up to 18 monthsThe investigators will record the number of preventable and non preventable adverse drug events

Countries

Italy

Contacts

Primary ContactMaria Pierro, MD, PhD
maria.pierro@poliambulanza.it+39030351
Backup ContactElena Vailati
elena.vailati@poliambulanza.it+39030351

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026