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

Neonatal Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04039152
• Other study ID #: AssiutUU
• Status: Completed
• Start date: January 3, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: December 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 30 Days

Eligibility

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.

Related Conditions & MeSH terms

• Neonatal Sepsis

Intervention

Other:
• locally adapted neonatal sepsis treatment protocol
the neonatal sepsis treatment protocol was modified according to the local antibiotics susceptibility patterns

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	14-days mortality in each group	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	6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase
Primary	28-days mortality in each group	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	6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase
Secondary	Average Length of hospital stay in each group	In days	6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase
Secondary	30-day readmission in each group	number of patients readmitted within 30 days from discharge	6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase