Clinical trial NCT05743816: Neonatal Antimicrobial Resistance and Outcome
Official title: Neonatal Antimicrobial Resistance and Outcome (neoAMRO)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neonatal Infection
Keywords: Infection
Lead sponsor: St George's, University of London
Sponsor class: OTHER
Collaborators: name: Antibiotic Research UK
First posted: 2023-02-24
Enrollment: 800
Sex: ALL
Minimum age (years): 28
Maximum age (years): 12
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonatal units

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.

Eligibility criteria: Inclusion criteria:

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

Primary outcomes:
measure: Identifying infections
timeFrame: 5 years
measure: Clinical characteristics
timeFrame: 5 years
measure: Management of infections
timeFrame: 5 years
Secondary outcomes:
measure: Comparing bacterial infections
timeFrame: 5 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St George's University of London
Study officials:
affiliation: St George's, University of London
name: Eva Galiza, MD
role: PRINCIPAL_INVESTIGATOR
References: