Neonatal Antimicrobial Resistance and Outcome

Recruiting

• Conditions: Neonatal Infection

• Registration Number: NCT05743816
• Lead Sponsor: St George's, University of London

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.

Detailed Description

The neonIN surveillance network captures data on episodes of invasive neonatal infection on a web-based database. Over 30 UK neonatal units currently contribute to this database in real-time. An episode of neonatal infection is defined as a positive culture collected from a normally sterile site such as the blood, cerebrospinal fluid (CSF) or urine (via catheter or suprapubic aspirate) for which clinicians prescribed at least five days of appropriate antibiotics. Clinical, demographic and microbiological data (including antimicrobial susceptibilities) are collected using a standardised online questionnaire. Denominator data regarding the total number of live-births and neonatal-admissions are collected for each neonatal unit.

Through our study we aim to understand and describe better those infections and risk factors that lead to death. The case-control study will enable us to determine if gaps in optimal management, such as the wrong antibiotic or the wrong dose, are associated with poor outcomes. We can then translate such information into practice and develop / improve clinical guidance in order to improve outcomes.

For the purpose of this study, we will request information on the baby's status (alive/died/not known) at 28 days after the positive culture was obtained. If the baby is alive, then this baby becomes eligible as a control. If the baby has died, then further details will be sought including the date of death and whether death was attributed to the infection.

Study Timeline

• Study Start: 2019-07-30
• Status Verified: 2023-02
• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-24
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01
• Primary Completion: 2023-09-30
• Study Completion: 2024-02-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical characteristics	5 years	To define the clinical characteristics of babies dying from infections
Management of infections	5 years	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
Identifying infections	5 years	To identify the infections leading to death in babies on UK neonatal units

Secondary Outcome Measures

Name	Time	Method
Comparing bacterial infections	5 years	In a case-control study we will assess the hypothesis that babies who die from bacterial infections on neonatal units do so because they receive inappropriate antibiotic management. To do this we will compare babies who die from bacterial infections with babies who survive bacterial infections on a range of factors including appropriateness, dose and timeliness of antibiotic use.

Trial Locations

Locations (1)

St George's University of London; 🇬🇧 London, United Kingdom