Neonatal InfectionneoAMRONCT05743816
Neonatal Antimicrobial Resistance and Outcome
An observational study of Neonatal Infection, run by St George's, University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 days to 12 months
- Conditions the study is for
- Neonatal Infection
- How many people
- 800 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jul 2019to 29 Feb 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 12 months
- All sexes
- Child
Study population: Neonatal units
Who may be able to join
- Infants on participating NNUs who have an episode of infection with a positive culture.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St George's University of London
London, SW17 0RE
Sana Ibrahim, BSc, +44 (0)208 725 5382, sibrahim@sgul.ac.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Neonatal Infection
- Keywords
- Infection
- Medical subject headings
- Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying infections
To identify the infections leading to death in babies on UK neonatal units
Measured: 5 years
Clinical characteristics
To define the clinical characteristics of babies dying from infections
Measured: 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
Measured: 5 years
Secondary outcomes (1)
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start30 Jul 2019
- Primary completion30 Sep 2023 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Antibiotic Research UK
- Responsible party
- Sponsor
- Investigators
- Eva Galiza, MD, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743816
- Sponsor's protocol ID
- 2019.0048
- Acronym
- neoAMRO
- Status last verified
- Feb 2023
- First submitted
- 14 Feb 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data will be made available to all researchers.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Antimicrobial Resistance and Outcome (neoAMRO)
- ClinicalTrials.gov ID
- NCT05743816
- Acronym / sponsor ID
- neoAMRO / 2019.0048
- Conditions
- Neonatal Infection
- Keywords
- Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- Antibiotic Research UK
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 28 days to 12 months
- Sex
- All
- Age groups
- Child
- Study population
- Neonatal units
Key inclusion criteria (1 listed)
- Infants on participating NNUs who have an episode of infection with a positive culture.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identifying infections
Time frame: 5 years
To identify the infections leading to death in babies on UK neonatal units
Clinical characteristics
Time frame: 5 years
To define the clinical characteristics of babies dying from infections
Management of infections
Time frame: 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
1 secondary outcome
Comparing bacterial infections
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: Yes. All collected individual participant data will be made available to all researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Galiza, MD principal investigator
St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Infection, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sana Ibrahim, BSc (02087255382, sibrahim@sgul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying infections (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.