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Clinical Impact of an Antibiotic Stewardship Program in a Neonatal Intensive Care Unit

Clinical Impact of an Antibiotic Stewardship Program in a Neonatal Intensive Care Unit at a Tertiary Care Hospital: A Prospective Quasi Experimental Clinical Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04039152
Enrollment
1200
Registered
2019-07-31
Start date
2019-01-03
Completion date
2020-12-31
Last updated
2024-04-23

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

Conditions

Neonatal Sepsis

Keywords

Antibiotics, Antimicrobial resistance, Antibiotic stewardship program, Neonatal intensive care unit, Neonatal sepsis

Brief summary

Antimicrobial resistance is one of the biggest and most urgent threat to global health. Initiating antimicrobial stewardship programs is one of the main efforts to control antimicrobial resistance. Implementing these programs in neonatal intensive care units (NICU)is very important and crucial despite of its difficulty, where antibiotics are used extensively. The aim of present study was to assess the clinical impact of implementing antibiotic stewardship program interventions at NICU.

Detailed description

Background: Implementing an antimicrobial stewardship program is one of the main efforts to control antimicrobial resistance. The present study aimed to assess the clinical impact of the antibiotics stewardship program (ASP) in the neonatal intensive care unit (NICU) of Assiut University Children's Hospital. Methods: The study was conducted in two phases from January 2019 to June 2020. The pre-ASP phase (603 patients) included making NICU-specific antibiograms, choosing the antibiotic use evaluation measures, conducting antibiotic use evaluations, and designing the ASP. The ASP intervention phase (597 patients) included implementation of the ASP, which involved modifying the neonatal sepsis treatment protocol according to the local antibiotic susceptibility patterns and measuring its clinical outcomes. Results: The ASP intervention phase showed a significant increase in the number of C-reactive protein tests, microbiological cultures/patient, the number of patients taking definitive therapy, and the number of pharmacist interventions/patient. The prescribing rates of antibiotics and their consumption levels were changed according to the NICU-specific antibiogram. There was a significant reduction in the 14-day and 28-day mortality of patients with late-onset sepsis after modifying the neonatal sepsis treatment protocol in the ASP intervention phase. Conclusion: ASP implementation was successful in improving antibiotic prescribing and patients outcomes.

Interventions

OTHERlocally adapted neonatal sepsis treatment protocol

the neonatal sepsis treatment protocol was modified according to the local antibiotics susceptibility patterns

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 30 Days
Healthy volunteers
Yes

Inclusion criteria

* Received antibiotics for more than 72 hours.

Exclusion criteria

* Hospital stay was less than 72 hours. * Did not receive any antibiotics during hospital stay.

Design outcomes

Primary

MeasureTime frameDescription
14-days mortality in each group6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phaseNumber of patients who died from neonatal sepsis at the 14th day of their hospital stay was compared in the Pre-ASP phase and the ASP intervention phase
28-days mortality in each group6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phaseNumber of patients who died from neonatal sepsis at the 28th day of their hospital stay was compared in the Pre-ASP phase and the ASP intervention phase

Secondary

MeasureTime frameDescription
Average Length of hospital stay in each group6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phaseIn days
30-day readmission in each group6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phasenumber of patients readmitted within 30 days from discharge

Countries

Egypt

Outcome results

None listed

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