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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| locally adapted neonatal sepsis treatment protocol | Other | the neonatal sepsis treatment protocol was modified according to the local antibiotics susceptibility patterns |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Neonates admitted to NICU and received antibiotics for more than 72 hours
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| Name | Affiliation | Role |
|---|---|---|
| Neveen H. Abdelaal, M.sc. | Department of Pharmacy and Medical Supplies, Assiut University Children's Hospital, Egypt | Principal Investigator |
| 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 Chair |
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut University | Asyut | 71511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40988069 | Derived | Abdelaal NH, Aziz NHRA, Abdelaziz AM, Khalil SBH, Abdel-Latif MMM. Clinical impact of an antibiotic stewardship program in a neonatal intensive care unit at a tertiary care hospital: a prospective quasi-experimental clinical study. J Pharm Health Care Sci. 2025 Sep 23;11(1):81. doi: 10.1186/s40780-024-00404-3. |
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Participant data will not be shared
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| ID | Term |
|---|---|
| D000071074 | Neonatal Sepsis |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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|
| 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |