NCT07013864

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
Last Updated

June 10, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

June 2, 2025

Last Update Submit

June 2, 2025

Conditions

Staphylococcus HaemolyticusStaphylococcal InfectionsSepsisCatheter-Related InfectionsInfant, NewbornIntensive Care Units, NeonatalCross InfectionDrug Resistance, Bacterial

Outcome Measures

Primary Outcomes (1)

  • Incidence of Staphylococcus haemolyticus Infections Associated with Central Venous Catheters (CVCs)

    January 1, 2023 - December 31, 2023

Eligibility Criteria

AgeUp to 2 Months
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

France

Saint-Denis, France, France

Location

MeSH Terms

Conditions

Staphylococcal InfectionsSepsisCatheter-Related InfectionsCross Infection

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsIatrogenic DiseaseDisease Attributes

Study Design

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

Study Record Dates

First Submitted

June 2, 2025

First Posted

June 10, 2025

Study Start

July 1, 2024

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

June 10, 2025

Record last verified: 2025-05

Locations

FR(1)