Staphylococcus Haemolyticus in the Neonatal Intensive Car... | NCT07013864

Studies
Staphylococcus Haemolyticus in the Neonatal Intensive Care Unit of CHSD in 2023: Analysis and Trends

NCT07013864

Sponsor

Centre Hospitalier de Saint-Denis

Status

Completed

Last Update Posted

Jun 10, 2025Actual

Enrollment

28Actual

Phase

Not provided

Conditions

Staphylococcus Haemolyticus
Staphylococcal Infections
Sepsis
Catheter-Related Infections
Infant, Newborn
Intensive Care Units, Neonatal
Cross Infection
Drug Resistance, Bacterial

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2024Actual

Primary Completion Date

Sep 30, 2024Actual

Completion Date

Sep 30, 2024Actual

First Submitted Date

Jun 2, 2025

First Submission Date that Met QC Criteria

Jun 2, 2025

First Posted Date

Jun 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2025

Last Update Posted Date

Jun 10, 2025Actual

Description Module

Brief 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. The goal is to understand whether these infections have increased and how they affected the babies' health.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Staphylococcus haemolyticus Infections Associated with Central Venous Catheters (CVCs)		January 1, 2023 - December 31, 2023

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- No exclusion criteria

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

2 Months

Standard Ages

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.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
France		Saint-Denis	France		France

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D013203	Staphylococcal Infections
D018805	Sepsis
D055499	Catheter-Related Infections
D003428	Cross Infection

Ancestor Terms

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D007049	Iatrogenic Disease
D020969	Disease Attributes