Staphylococcus HaemolyticusNCT07013864
Staphylococcus Haemolyticus in the Neonatal Intensive Care Unit of CHSD in 2023: Analysis and Trends
An observational study of Staphylococcus Haemolyticus and Staphylococcal Infections, run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial summary
This study looks at cases of Staphylococcus haemolyticus infections in newborns hospitalized in the Neonatal Intensive Care Unit (NICU) at the Saint-Denis Hospital in 2023. Researchers reviewed the medical records of 28 infants who had this bacteria found in their blood or catheter cultures. Read more about this study
- Who is it for?
- Ages Up to 2 months
- Conditions the study is for
- Staphylococcus Haemolyticus, Staphylococcal Infections, Sepsis
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2024to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 2 months
- All sexes
- Child
Study population: The inclusion criteria were all newborns in 2023, hospitalized in the Neonatal and Neonatal Resuscitation department of the Saint-Denis Hospital Centre with at least one isolation of S. haemolyticus in blood cultures or catheter cultures.
Who may be able to join
- Newborns in 2023
- hospitalized in the Neonatal and Neonatal Resuscitation department of the Saint-Denis
- At least one isolation of S. haemolyticus in blood cultures or catheter cultures
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
This study looks at cases of Staphylococcus haemolyticus infections in newborns hospitalized in the Neonatal Intensive Care Unit (NICU) at the Saint-Denis Hospital in 2023. Researchers reviewed the medical records of 28 infants who had this bacteria found in their blood or catheter cultures. The goal is to understand whether these infections have increased and how they affected the babies' health.
- Conditions
- Staphylococcus Haemolyticus, Staphylococcal Infections, Sepsis, Catheter-Related Infections, Infant, Newborn, Intensive Care Units, Neonatal
- Medical subject headings
- Staphylococcal Infections, Sepsis, Catheter-Related Infections, Cross Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Staphylococcus haemolyticus Infections Associated with Central Venous Catheters (CVCs)
Measured: January 1, 2023 - December 31, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 Jul 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus HaemolyticusStudies of the same condition, open and under way.
- 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013864
- Sponsor's protocol ID
- 0086_NEONATOLOGIE
- Status last verified
- May 2025
- First submitted
- 2 Jun 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staphylococcus Haemolyticus in the Neonatal Intensive Care Unit of CHSD in 2023: Analysis and Trends
- ClinicalTrials.gov ID
- NCT07013864
- Acronym / sponsor ID
- 0086_NEONATOLOGIE
- Conditions
- Staphylococcus Haemolyticus, Staphylococcal Infections, Sepsis, Catheter-Related Infections, Infant, Newborn, Intensive Care Units, Neonatal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 10 Jun 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.
This study looks at cases of Staphylococcus haemolyticus infections in newborns hospitalized in the Neonatal Intensive Care Unit (NICU) at the Saint-Denis Hospital in 2023. Researchers reviewed the medical records of 28 infants who had this bacteria found in their blood or catheter cultures. The goal is to understand whether these infections have increased and how they affected the babies' health.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Age groups
- Child
- Study population
- The inclusion criteria were all newborns in 2023, hospitalized in the Neonatal and Neonatal Resuscitation department of the Saint-Denis Hospital Centre with at least one isolation of S. haemolyticus in blood cultures or catheter cultures.
Key inclusion criteria (3 listed)
- Newborns in 2023
- hospitalized in the Neonatal and Neonatal Resuscitation department of the Saint-Denis
- At least one isolation of S. haemolyticus in blood cultures or catheter cultures
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Staphylococcus haemolyticus Infections Associated with Central Venous Catheters (CVCs)
Time frame: January 1, 2023 - December 31, 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
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 Staphylococcus Haemolyticus and Staphylococcal Infections, run by Centre Hospitalier de Saint-Denis 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 3 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: finished, as of the sponsor's last update on 10 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Staphylococcus haemolyticus Infections Associated with Central Venous Catheters (CVCs) (time frame: January 1, 2023 - December 31, 2023). 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 10 Jun 2025.