NCT05743816

Brief Summary

This is a multicentre observational study involving NNUs across the UK. Study personnel (Neonatologists and research Nurses) from these NNUs will identify eligible babies in whom a positive culture has been obtained. This study will help identify the infections leading to death in babies on UK neonatal units, define the clinical characteristics of babies dying from infections, and describe the management of babies dying from infections with a specific focus in their antimicrobial treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 30, 2019

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

4.2 years

First QC Date

February 14, 2023

Last Update Submit

February 28, 2023

Conditions

Neonatal Infection

Keywords

Infection

Outcome Measures

Primary Outcomes (3)

  • Identifying infections

    To identify the infections leading to death in babies on UK neonatal units

    5 years

  • Clinical characteristics

    To define the clinical characteristics of babies dying from infections

    5 years

  • Management of infections

    To describe the management of babies dying from infections with a specific focus in their antimicrobial treatment and the antimicrobial resistance profiles of the relevant organisms

    5 years

Secondary Outcomes (1)

  • Comparing bacterial infections

    5 years

Eligibility Criteria

Age28 Days - 12 Months
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Neonatal units

You may qualify if:

  • Infants on participating NNUs who have an episode of infection with a positive culture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St George's University of London

London, SW17 0RE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Infections

Study Officials

  • Eva Galiza, MD

    St George's, University of London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sana Ibrahim, BSc

CONTACT

02087255382sibrahim@sgul.ac.uk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2023

First Posted

February 24, 2023

Study Start

July 30, 2019

Primary Completion

September 30, 2023

Study Completion

February 29, 2024

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

All collected individual participant data will be made available to all researchers.

Shared Documents
CSR
Time Frame
Clinical Study Report will be made available in the form of a publication within 6 months of study end date.
Access Criteria
Only team members who have access to the database will be able to view study data for their individual site. Sites can also view reports of the general study on the database. The lead site will have capacity to review the full study data for statistical analysis.

Locations

GB(1)