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Clinical Trials/NCT05742490
NCT05742490
Recruiting
Not Applicable

Neonatal Infection Surveillance Database

St George's, University of London1 site in 1 country12,000 target enrollmentDecember 16, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neonatal Infection
Sponsor
St George's, University of London
Enrollment
12000
Locations
1
Primary Endpoint
Features of bacterial infections
Status
Recruiting
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 16, 2013
End Date
November 22, 2028
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

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

Study Sites (1)

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