Neonatal Infection Surveillance Database

Recruiting

• Conditions: Neonatal Infection

• Registration Number: NCT05742490
• Lead Sponsor: St George's, University of London

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.

Study Timeline

• Study Start: 2013-12-16
• Status Verified: 2023-01
• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-02-14
• Last Update Submitted: 2023-02-14
• Study First Posted: 2023-02-24
• Last Update Posted: 2023-02-24
• Primary Completion: 2023-11-22
• Study Completion: 2028-11-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12000

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Features of bacterial infections	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	6 months	Collection of neonIN data on episodes of significant neonatal bacterial infections in NNUs recruiting to neonIN
Antibiotic susceptibility	6 months	Collection of neonIN data on susceptibility profiles of significant neonatal bacterial infections

Trial Locations

Locations (1)

St George's University of London; 🇬🇧 London, United Kingdom