Antibiotic Stewardship to Prevent Early Sepsis in Preterm Infants

NCT06930911 | Active Not Recruiting

• 1 other identifier: 25-5057
• Study Type: observational
• Target: 711
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prematurity, Infections

Outcome Measures

Primary Outcomes (1)

• Rate of premature infants treated with antibiotics

  During the first three days of life

Study Arms (1)

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

Interventions

Antibiotic therapy BIOLOGICAL

Evaluating antibiotic exposure in premature infants before 35 weeks in a tertiary care neonatal unit

Preterm infant

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• \- Parent refusal

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Croix Rousse hospital

Lyon, 69004, France

Location

MeSH Terms

Conditions

Premature Birth; Infections

Interventions

Anti-Infective Agents

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: February 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

FR (1)