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

NCT04039152 | Completed

• 1 other identifier: AssiutUU
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Sepsis

Keywords

Antibiotics; Antimicrobial resistance; Antibiotic stewardship program; Neonatal intensive care unit; Neonatal sepsis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

• 30-day readmission in each group

  6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase

Study Arms (2)

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

Interventions

locally adapted neonatal sepsis treatment protocol OTHER

the neonatal sepsis treatment protocol was modified according to the local antibiotics susceptibility patterns

Also known as: implementing a new antibiotic dosing protocol, increasing the number of ordered microbiological cultures, the number of C-reactive protein (CRP) tests per patient.

The antibiotics stewardship program intervention phase

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Received antibiotics for more than 72 hours.

You may not qualify if:

• Hospital stay was less than 72 hours.
• Did not receive any antibiotics during hospital stay.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71511, Egypt

Location

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: July 31, 2019
• Study Start: January 3, 2019
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)