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RecruitingNCT05742490neonINUpdated Feb 24, 2023

Neonatal Infection Surveillance Database

An observational study in Neonatal Infection, sponsored by St George's, University of London. Recruiting at 1 site in United Kingdom. Open to participants aged 1 Minute to 12 Months. Per ClinicalTrials.gov, last updated 2023-02-24.

Sponsored by St George's, University of London · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2023, 2 years 11 months ago, but the record still lists the study as recruiting.
  • Started Dec 2013; still recruiting 12 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12,000
Ages
1 Minute to 12 Months
Sex
All
01

Study 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. 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.

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Conditions studied

  • Neonatal Infection
03

In context

Lead sponsor

St George's, University of London is the lead sponsor of 106 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Minute to 12 Months
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Eligible infants will be identified from Neonatal Units

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Infants on participating Neonatal Units who have an episode of infection with a positive culture

Exclusion criteria

Exclusion Criteria:

-

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12,000 participants (estimated)
Target follow-up
28 Days
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Incidence of infection

    Collection of neonIN data on episodes of significant neonatal bacterial infections in NNUs recruiting to neonIN

    Time frame: 6 months

  2. Antibiotic susceptibility

    Collection of neonIN data on susceptibility profiles of significant neonatal bacterial infections

    Time frame: 6 months

  3. 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

    Time frame: 6 months

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Study locations

1 of 1 sites recruiting
  • St George's University of London
    London, SW17 0RE, United Kingdom
    Recruiting
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References and documents

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 29954881 ↗
  • Wang 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 30425112 ↗
  • Cailes 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 29074716 ↗
  • Cailes 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 29208666 ↗
  • Sapuan 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05742490
Responsible party
Sponsor
First posted
Feb 24, 2023
Start date
Dec 16, 2013
Primary completion
Nov 22, 2023 (estimated)
Completion
Nov 22, 2028 (estimated)
Last update
Feb 24, 2023

Study contacts

Sana Ibrahim, BSc
Contact
sibrahim@sgul.ac.uk
+44 (0)208 725 5382
Eva Galiza, MD
principal investigator · St George's, University of London

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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