Neonatal Antimicrobial Resistance and Outcome (neoAMRO)

Neonatal Antimicrobial Resistance and Outcome (neoAMRO)

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.

Study Overview

• Status: Recruiting
• Conditions: Neonatal Infection

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 Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

• Study Contact: Name: Sana Ibrahim, BSc; Phone Number: 02087255382; Email: sibrahim@sgul.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SW17 0RE
    • Recruiting
    • St George's University of London
    • Contact: Sana Ibrahim, BSc; Phone Number: +44 (0)208 725 5382; Email: sibrahim@sgul.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 1 year (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Neonatal units

Description

Inclusion criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing bacterial infections	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.	5 years

Collaborators and Investigators

• Sponsor: St George's, University of London
• Collaborators: Antibiotic Research UK
• Investigators: Principal Investigator: Eva Galiza, MD, St George's, University of London

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2019
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): February 29, 2024

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Infection
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 2019.0048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected individual participant data will be made available to all researchers.
• IPD Sharing Time Frame: Clinical Study Report will be made available in the form of a publication within 6 months of study end date.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No