NCT05742490

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,000

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Dec 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Dec 2013Nov 2028

Study Start

First participant enrolled

December 16, 2013

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2023

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2028

Expected
Last Updated

February 24, 2023

Status Verified

January 1, 2023

Enrollment Period

9.9 years

First QC Date

January 19, 2023

Last Update Submit

February 14, 2023

Conditions

Neonatal Infection

Outcome Measures

Primary Outcomes (3)

  • Incidence of infection

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

    6 months

  • Antibiotic susceptibility

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

    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

    6 months

Eligibility Criteria

Age1 Minute - 12 Months
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Eligible infants will be identified from Neonatal Units

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St George's University of London

London, SW17 0RE, United Kingdom

RECRUITING

Related Publications (5)

  • 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.

    PMID: 29954881BACKGROUND

  • 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.

    PMID: 30425112BACKGROUND

  • 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.

    PMID: 29074716BACKGROUND

  • 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.

    PMID: 29208666BACKGROUND

  • 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.

    PMID: 27867063BACKGROUND

Study Officials

  • Eva Galiza, MD

    St George's, University of London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sana Ibrahim, BSc

CONTACT

+44 (0)208 725 5382sibrahim@sgul.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2023

First Posted

February 24, 2023

Study Start

December 16, 2013

Primary Completion

November 22, 2023

Study Completion (Estimated)

November 22, 2028

Last Updated

February 24, 2023

Record last verified: 2023-01

Locations

GB(1)