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Completed

NCT Number: NCT04039152

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

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.

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Key information

Conditions

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

Age range

1 day–30 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut University

Asyut, 71511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

locally adapted neonatal sepsis treatment protocol

Other

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.

Primary outcomes

  1. 14-days mortality in each group

    Time frame: 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase

    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

  2. 28-days mortality in each group

    Time frame: 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase

    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

Secondary outcomes

  1. Average Length of hospital stay in each group

    Time frame: 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase

    In days

  2. 30-day readmission in each group

    Time frame: 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase

    number of patients readmitted within 30 days from discharge

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 31, 2019
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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