Prematurity, InfectionsBACTINEONCT06930911
Antibiotic Stewardship to Prevent Early Sepsis in Preterm Infants
An observational study of Prematurity, Infections, run by Hospices Civils de Lyon at 1 site in France.
Trial 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)). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prematurity, Infections
- What is being tested?
- Antibiotic therapy
- How many people
- 711 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2025to 1 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Infants born before 35 weeks hospitalized in neonatology at croix rousse hospital.
Who may be able to join
- - infants born at a gestational age of less than 35 weeks - Born between January 1, 2021 and December 31, 2023
Who cannot join
- - Parent refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Prematurity, Infections
- Being tested
- Antibiotic therapy
- Medical subject headings
- Premature Birth, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic therapyBiological
Evaluating antibiotic exposure in premature infants before 35 weeks in a tertiary care neonatal unit
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Antibiotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of premature infants treated with antibiotics
Measured: During the first three days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start1 Feb 2025
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prematurity, InfectionsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 711 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930911
- Sponsor's protocol ID
- 25-5057
- Acronym
- BACTINEO
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Antibiotic Stewardship to Prevent Early Sepsis in Infants Less Than 35 Weeks of Age, With a View to Its Optimization
- ClinicalTrials.gov ID
- NCT06930911
- Acronym / sponsor ID
- BACTINEO / 25-5057
- Conditions
- Prematurity, Infections
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 711 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm infant | – | Biological: Antibiotic therapyPatients born before 35 weeks and admitted in the tertiary neonatal unit of the Croix Rousse between 01/01/2021 and 31/12/2023. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Infants born before 35 weeks hospitalized in neonatology at croix rousse hospital.
Key inclusion criteria (1 listed)
- - infants born at a gestational age of less than 35 weeks - Born between January 1, 2021 and December 31, 2023
Key exclusion criteria (1 listed)
- - Parent refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic therapyEvaluating antibiotic exposure in premature infants before 35 weeks in a tertiary care neonatal unit | Biological | Preterm infant |
Primary outcome
Rate of premature infants treated with antibiotics
Time frame: During the first three days of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity, Infections, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of premature infants treated with antibiotics (time frame: During the first three days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.