Neonatal Antimicrobial Resistance & Outcome

Status Recruiting

Clinical Trial Summary

This is a multicentre observational study involving NNUs across the UK. Study personnel (Neonatologists and research Nurses) from these NNUs will identify eligible babies in whom a positive culture has been obtained. This study will help identify the infections leading to death in babies on UK neonatal units, define the clinical characteristics of babies dying from infections, and describe the management of babies dying from infections with a specific focus in their antimicrobial treatment.

Clinical Trial Description

The neonIN surveillance network captures data on episodes of invasive neonatal infection on a web-based database. Over 30 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. Denominator data regarding the total number of live-births and neonatal-admissions are collected for each neonatal unit. Through our study we aim to understand and describe better those infections and risk factors that lead to death. The case-control study will enable us to determine if gaps in optimal management, such as the wrong antibiotic or the wrong dose, are associated with poor outcomes. We can then translate such information into practice and develop / improve clinical guidance in order to improve outcomes. For the purpose of this study, we will request information on the baby's status (alive/died/not known) at 28 days after the positive culture was obtained. If the baby is alive, then this baby becomes eligible as a control. If the baby has died, then further details will be sought including the date of death and whether death was attributed to the infection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05743816
Study type	Observational [Patient Registry]
Source	St George's, University of London
Contact	Sana Ibrahim, BSc
Phone	02087255382
Email	sibrahim@sgul.ac.uk
Status	Recruiting
Phase
Start date	July 30, 2019
Completion date	February 29, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04200807` - Non-invasive Measurement of Neonatal Central and Peripheral Hemodynamics
Recruiting	`NCT05695196` - Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant	Phase 1
Completed	`NCT01729000` - Study to Determine if Gloving in Addition to Hand Hygiene Will Prevent Invasive Infections and Necrotizing Enterocolitis	N/A
Completed	`NCT06413056` - Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection	Phase 4
Completed	`NCT03247920` - Reduction of Intravenous Antibiotics In Neonates	Phase 4
Completed	`NCT02486783` - Infection, Sepsis and Meningitis in Surinamese Neonates	N/A
Recruiting	`NCT06194396` - Effect of Chlorhexidine Versus Alcohol on Infections in Neonates	N/A
Active, not recruiting	`NCT05343403` - Parental Participation on the Neonatal Ward - the neoPARTNER Study
Recruiting	`NCT04416373` - COVID-19 and Pregnancy Outcomes
Completed	`NCT01540162` - Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement	N/A
Withdrawn	`NCT03673566` - Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - CHMCO	N/A
Completed	`NCT04883801` - Clinical Outcomes of Newborns Born to Pregnant Women With and Without COVID-19
Terminated	`NCT05379452` - Outcomes of Neonates Born to Mothers With SARS-CoV-2 Infection in Shanghai
Active, not recruiting	`NCT04718220` - Safety, Testing/Transmission, and Outcomes in Pregnancies With COVID-19	N/A
Not yet recruiting	`NCT06102044` - Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania	Phase 3
Active, not recruiting	`NCT04433364` - COPE - COVID-19 in Pregnancy and Early Childhood
Completed	`NCT03383211` - Immune Response to BCG Vaccination in Neonates Born to HIV and LTBI Infected and Non-infected Mothers
Completed	`NCT04893343` - Antibiotic Use in a Neonatal Intensive Care Unit Practicing Integrative Medicine
Withdrawn	`NCT03673579` - Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - MHSB	N/A
Completed	`NCT04206878` - Evaluating the Feasibility of Point of Care Birth Testing in Eswatini

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Neonatal Antimicrobial Resistance and Outcome — neoAMRO

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms