Clinical Impact of an Antibiotic Stewardship Program in a Neonatal Intensive Care Unit
- Conditions
- Neonatal Sepsis
- Interventions
- Other: locally adapted neonatal sepsis treatment protocol
- Registration Number
- NCT04039152
- Lead Sponsor
- Assiut University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1200
- Received antibiotics for more than 72 hours.
- Hospital stay was less than 72 hours.
- Did not receive any antibiotics during hospital stay.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description The antibiotics stewardship program intervention phase locally adapted neonatal sepsis treatment protocol The ASP intervention phase 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.
- Primary Outcome Measures
Name Time Method 28-days mortality in each group 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase Number 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
14-days mortality in each group 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase Number 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
- Secondary Outcome Measures
Name Time Method Average Length of hospital stay in each group 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase In days
30-day readmission in each group 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase number of patients readmitted within 30 days from discharge
Trial Locations
- Locations (1)
Assiut University
🇪🇬Assiut, Egypt