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

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Sepsis
• Intervention / Treatment: Other: locally adapted neonatal sepsis treatment protocol

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.

• Study Type: Observational
• Enrollment (Actual): 1200

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71511
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 month (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Neonates admitted to NICU and received antibiotics for more than 72 hours

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The pre-antibiotics stewardship program phase; This phase included making NICU-specific antibiograms, choosing the antibiotic use evaluation measures, conducting antibiotic use evaluations, and designing the antibiotics stewardship program (ASP).
The antibiotics stewardship program intervention phase; 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.	Other: locally adapted neonatal sepsis treatment protocol; the neonatal sepsis treatment protocol was modified according to the local antibiotics susceptibility patterns; Other Names: implementing a new antibiotic dosing protocol, increasing the number of ordered microbiological cultures, the number of C-reactive protein (CRP) tests per patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Neveen H. Abdelaal, M.sc., Department of Pharmacy and Medical Supplies, Assiut University Children's Hospital, Egypt; Study Chair: Nafisa H. Abdel Aziz, PhD, Department of Pediatrics, Faculty of Medicine, Assiut University, Egypt; Study Chair: Asmaa M. Abdelaziz, PhD, Department of Clinical Pathology, Faculty of Medicine, Assiut University, Egypt; Study Director: Sahar B. Khalil, PhD, Department of Clinical Pharmacy, Faculty of Pharmacy, Assiut University, Egypt; Study Director: Mohamed M Abdel-Latif, PhD, Department of Clinical Pharmacy, Faculty of Pharmacy, Assiut University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2019
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: July 29, 2019
• First Submitted That Met QC Criteria: July 29, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Antibiotics; Antimicrobial resistance; Neonatal sepsis; Neonatal intensive care unit; Antibiotic stewardship program
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Neonatal Sepsis; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: AssiutUU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No