Neonatal Antimicrobial Resistance and Outcomes (neoAMRO)

• Research type

  Research Study

• Full title

  Neonatal Antimicrobial Resistance and Outcome (neoAMRO)

• IRAS ID

  268175

• Contact name

  Paul T Heath

• Contact email

  pheath@sgul.ac.uk

• Sponsor organisation

  Joint Research & Enterprise Services, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust

• Duration of Study in the UK

  2 years, 11 months, 30 days

• Research summary

  Infections are an important cause of deaths in babies during their first weeks of life. Infection is typically non-specific in presentation. This means clinicians must start antibiotics early and “guess” which antibiotics to use. We know from our surveillance network that in 10-20% of cases the antibiotics chosen will not be the correct ones. A small study showed that when this mismatch occurred the babies had a high mortality. We wish to collect information on 800 neonatal infections, identify the pathogens associated with deaths and determine if gaps in optimal antibiotic treatment are related to poor outcomes.

  Over this 30 month prospective period the primary objectives are:
  • To identify the infections leading to death in babies on UK neonatal units
  • To define the clinical characteristics of babies dying from infections
  • To describe the management of babies dying from infections with a specific focus on their antimicrobial treatment and the antimicrobial resistance profiles of the relevant organisms.

  The secondary objective is to 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 in the case-control
  study who die from bacterial infections with babies who survive bacterial infections on a range of factors including appropriateness, dose and timeliness of antibiotic use.

  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.

• REC name

  North East - York Research Ethics Committee

• REC reference

  19/NE/0245

• Date of REC Opinion

  19 Jul 2019

• REC opinion

  Favourable Opinion