Antibiotic Stewardship to Prevent Early Sepsis in Preterm Infants (BACTINEO)

April 9, 2025 updated by: Hospices Civils de Lyon

Analysis of Antibiotic Stewardship to Prevent Early Sepsis in Infants Less Than 35 Weeks of Age, With a View to Its Optimization

Early onset sepsis (EOS) occurs in newborns within the first 72 hours of life, and is rare, about 0.8 cases per 1000 births (1). It is more frequent in premature infants and potentially more severe (as much as 75% of deaths has been reported in extreme premature infants (1)). Infection is considered as confirmed when blood or cerebral fluid cultures detect a pathogen (1). It is considered probable when cultures are negative, but there are clinical (fever, hemodynamic failure, severe respiratory condition) and biological (inflammatory markers) signs suggestive of infection. In 2017, French recommendations for prevention of EOS in term and near-term infants has been proposed. However, to date, there are no recommendations for the population of premature newborns, and there are discrepancies in practices antibiotic stewardship to prevent early sepsis in infants born before 35 weeks. Preterm infants are more exposed to EOS than infants born closer to term. The incidence is inversely proportional to gestational age, reaching 32 cases per 1000 births in infants born between 22 and 24 weeks. Infection is a major cause of mortality and morbidity in premature newborns, because of the immaturity of their immune system. The death rate reach 50% in infants born between 22 and 28 weeks. For these reasons, probabilistic antibiotic therapy is prescribed at admission in Neonatology in 35 to 50% of very premature babies. But it appears that the prescription of antibiotics is not correlated with the incidence of EOS, with overuse of antibiotics, related to the fear of infection in these fragile patients. However, exposure to antibiotics induces gut dysbiosis, which is the main risk factor of necrotizing enterocolitis, a potentially severe disease occurring specifically in preterm infants. It is therefore important to optimize antibiotic stewardship in the days following birth, to improve the quality of care. To this end, we shall analyse antibiotic prescription practices and the rate of EOS in premature newborns hospitalized in a tertiary care unit at the Croix Rousse university hospital.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

711

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69004
        • Croix Rousse Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Infants born before 35 weeks hospitalized in neonatology at croix rousse hospital.

Description

Inclusion Criteria:

  • - infants born at a gestational age of less than 35 weeks - Born between January 1, 2021 and December 31, 2023

Exclusion Criteria:

  • - Parent refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Preterm infant
Patients born before 35 weeks and admitted in the tertiary neonatal unit of the Croix Rousse between 01/01/2021 and 31/12/2023.
Biological: Antibiotic therapy
Evaluating antibiotic exposure in premature infants before 35 weeks in a tertiary care neonatal unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of premature infants treated with antibiotics
Time Frame: During the first three days of life
During the first three days of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

April 9, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-5057

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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