Clinical Trials Directory

Trials / Completed

CompletedNCT04039152

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
Phase
Study type
Observational
Enrollment
1,200 (actual)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
1 Day – 30 Days
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERlocally adapted neonatal sepsis treatment protocolthe neonatal sepsis treatment protocol was modified according to the local antibiotics susceptibility patterns

Timeline

Start date
2019-01-03
Primary completion
2020-06-30
Completion
2020-12-31
First posted
2019-07-31
Last updated
2024-04-23

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04039152. Inclusion in this directory is not an endorsement.