Neonatal InfectionneonINNCT05742490
Neonatal Infection Surveillance Database
An observational study of Neonatal Infection, run by St George's, University of London at 1 site in United Kingdom.
Trial summary
NeonIN is a is a neonatal infection surveillance database which will facilitate active surveillance for bacterial infections through a network of neonatal units, using standardised definitions, proformas and microbiological techniques. Read more about this study
- Who is it for?
- Ages 1 minute to 12 months
- Conditions the study is for
- Neonatal Infection
- How many people
- 12,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Dec 2013to 22 Nov 2028
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 minute to 12 months
- All sexes
- Child
Study population: Eligible infants will be identified from Neonatal Units
Who may be able to join
- Infants on participating Neonatal Units who have an episode of infection with a positive culture
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
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
NeonIN is a is a neonatal infection surveillance database which will facilitate active surveillance for bacterial infections through a network of neonatal units, using standardised definitions, proformas and microbiological techniques. The centralised and secure web-based database will allow real-time entry of data and rapid and timely analysis of results.
Read the detailed description
The neonIN surveillance network captures data on episodes of invasive neonatal infection on a web-based database (www.neonin.org.uk). Over 25 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, and denominator data regarding the total number of live-births and neonatal-admissions are collected for each neonatal unit.
- Conditions
- Neonatal Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of infection
Collection of neonIN data on episodes of significant neonatal bacterial infections in NNUs recruiting to neonIN
Measured: 6 months
Antibiotic susceptibility
Collection of neonIN data on susceptibility profiles of significant neonatal bacterial infections
Measured: 6 months
Features of bacterial infections
Collection of neonIN data on gestation, birth weight, age of onset, clinical presentation and prior antibiotic use of significant neonatal bacterial infections
Measured: 6 months
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 start16 Dec 2013
- Primary completion22 Nov 2023 (estimated)
- Study completion22 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,000 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Galiza, MD, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742490
- Sponsor's protocol ID
- 05.0093
- Acronym
- neonIN
- Status last verified
- Jan 2023
- First submitted
- 19 Jan 2023
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gkentzi D, Kortsalioudaki C, Cailes BC, Zaoutis T, Kopsidas J, Tsolia M, Spyridis N, Siahanidou S, Sarafidis K, Heath PT, Dimitriou G; Neonatal Infection Surveillance Network in Greece. Epidemiology of infections and antimicrobial use in Greek Neonatal Units. Arch Dis Child Fetal Neonatal Ed. 2019 May;104(3):F293-F297. doi: 10.1136/archdischild-2018-315024. Epub 2018 Jun 28.
PubMed 29954881Wang J, Kortsalioudaki C, Heath PT, Buttery J, Clarke P, Gkentzi D, Anthony M, Tan K; neonIN network. Epidemiology and healthcare factors associated with neonatal enterococcal infections. Arch Dis Child Fetal Neonatal Ed. 2019 Sep;104(5):F480-F485. doi: 10.1136/archdischild-2018-315387. Epub 2018 Nov 13.
PubMed 30425112Cailes B, Kortsalioudaki C, Buttery J, Pattnayak S, Greenough A, Matthes J, Bedford Russell A, Kennea N, Heath PT; neonIN network. Antimicrobial resistance in UK neonatal units: neonIN infection surveillance network. Arch Dis Child Fetal Neonatal Ed. 2018 Sep;103(5):F474-F478. doi: 10.1136/archdischild-2017-313238. Epub 2017 Oct 26.
PubMed 29074716Cailes B, Kortsalioudaki C, Buttery J, Pattnayak S, Greenough A, Matthes J, Bedford Russell A, Kennea N, Heath PT; neonIN network. Epidemiology of UK neonatal infections: the neonIN infection surveillance network. Arch Dis Child Fetal Neonatal Ed. 2018 Nov;103(6):F547-F553. doi: 10.1136/archdischild-2017-313203. Epub 2017 Dec 5.
PubMed 29208666Sapuan S, Kortsalioudaki C, Anthony M, Chang J, Embleton ND, Geethanath RM, Gray J, Greenough A, Lal MK, Luck S, Pattnayak S, Reynolds P, Russell AB, Scorrer T, Turner M, Heath PT, Vergnano S. Neonatal listeriosis in the UK 2004-2014. J Infect. 2017 Mar;74(3):236-242. doi: 10.1016/j.jinf.2016.11.007. Epub 2016 Nov 17.
PubMed 27867063
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Infection Surveillance Database
- ClinicalTrials.gov ID
- NCT05742490
- Acronym / sponsor ID
- neonIN / 05.0093
- Conditions
- Neonatal Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- 16 Dec 2013 (actual)
- Primary completion
- 22 Nov 2023 (estimated)
- Study completion
- 22 Nov 2028 (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.
NeonIN is a is a neonatal infection surveillance database which will facilitate active surveillance for bacterial infections through a network of neonatal units, using standardised definitions, proformas and microbiological techniques. The centralised and secure web-based database will allow real-time entry of data and rapid and timely analysis of results.
Detailed description
The neonIN surveillance network captures data on episodes of invasive neonatal infection on a web-based database (www.neonin.org.uk). Over 25 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, and denominator data regarding the total number of live-births and neonatal-admissions are collected for each neonatal unit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
Who may qualify
- Ages
- 1 minute to 12 months
- Sex
- All
- Age groups
- Child
- Study population
- Eligible infants will be identified from Neonatal Units
Key inclusion criteria (1 listed)
- Infants on participating Neonatal Units who have an episode of infection with a positive culture
Key exclusion criteria (1 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
Incidence of infection
Time frame: 6 months
Collection of neonIN data on episodes of significant neonatal bacterial infections in NNUs recruiting to neonIN
Antibiotic susceptibility
Time frame: 6 months
Collection of neonIN data on susceptibility profiles of significant neonatal bacterial infections
Features of bacterial infections
Time frame: 6 months
Collection of neonIN data on gestation, birth weight, age of onset, clinical presentation and prior antibiotic use of significant neonatal bacterial infections
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Background: PubMed 29954881Gkentzi D, Kortsalioudaki C, Cailes BC, Zaoutis T, Kopsidas J, Tsolia M, Spyridis N, Siahanidou S, Sarafidis K, Heath PT, Dimitriou G; Neonatal Infection Surveillance Network in Greece. Epidemiology of infections and antimicrobial use in Greek Neonatal Units. Arch Dis Child Fetal Neonatal Ed. 2019 May;104(3):F293-F297. doi: 10.1136/archdischild-2018-315024. Epub 2018 Jun 28.
- Background: PubMed 30425112Wang J, Kortsalioudaki C, Heath PT, Buttery J, Clarke P, Gkentzi D, Anthony M, Tan K; neonIN network. Epidemiology and healthcare factors associated with neonatal enterococcal infections. Arch Dis Child Fetal Neonatal Ed. 2019 Sep;104(5):F480-F485. doi: 10.1136/archdischild-2018-315387. Epub 2018 Nov 13.
- Background: PubMed 29074716Cailes B, Kortsalioudaki C, Buttery J, Pattnayak S, Greenough A, Matthes J, Bedford Russell A, Kennea N, Heath PT; neonIN network. Antimicrobial resistance in UK neonatal units: neonIN infection surveillance network. Arch Dis Child Fetal Neonatal Ed. 2018 Sep;103(5):F474-F478. doi: 10.1136/archdischild-2017-313238. Epub 2017 Oct 26.
- Background: PubMed 29208666Cailes B, Kortsalioudaki C, Buttery J, Pattnayak S, Greenough A, Matthes J, Bedford Russell A, Kennea N, Heath PT; neonIN network. Epidemiology of UK neonatal infections: the neonIN infection surveillance network. Arch Dis Child Fetal Neonatal Ed. 2018 Nov;103(6):F547-F553. doi: 10.1136/archdischild-2017-313203. Epub 2017 Dec 5.
- Background: PubMed 27867063Sapuan S, Kortsalioudaki C, Anthony M, Chang J, Embleton ND, Geethanath RM, Gray J, Greenough A, Lal MK, Luck S, Pattnayak S, Reynolds P, Russell AB, Scorrer T, Turner M, Heath PT, Vergnano S. Neonatal listeriosis in the UK 2004-2014. J Infect. 2017 Mar;74(3):236-242. doi: 10.1016/j.jinf.2016.11.007. Epub 2016 Nov 17.
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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.
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 1 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: looking for participants now, as of the sponsor's last update on 24 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sana Ibrahim, BSc (+44 (0)208 725 5382, sibrahim@sgul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of infection (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT05742490, which also lists 5 linked publications.
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 24 Feb 2023.