Studying infection prevention methods for infants admitted to neonatal hospital units

Not Applicable

• Conditions: Assessment of bacterial colonisation pressure and colonisation dynamics in infants admitted to hospital neonatal units; Neonatal Diseases

• Registration Number: ISRCTN16979943
• Lead Sponsor: PENTA Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-01
• Last Update Posted: 28 August 2023
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

The target population for these surveillance activities are babies hospitalised in participating NICUs. Babies in all rooms of multi-room NICUs will be eligible.??

Neonatal intensive care units?:
At the level of the NICUs, the only inclusion criterion is the routine care of extremely premature babies (e.g. those <28 weeks gestational age).
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Babies – colonisation point prevalence survey surveillance:
All babies present in a participating NICU at 8 am on the morning of the day of the colonisation point prevalence surveys will be considered eligible with no clinical exclusion criteria. In fact, to establish colonisation pressure it is essential that a majority of babies on the unit at the time of survey be included. Babies whose parents specifically request that their baby does not contribute samples will be excluded.? ?

Babies – antibiotic use surveillance?:
An antibiotic point prevalence survey will be conducted of all babies admitted to a participating NICU at 8 am on the day of the survey. Data on prescribed antibiotics will be collected for all babies with an active (ongoing) antimicrobial prescription at that time. Babies present but not receiving antibiotics will contribute to the denominator.??

Exclusion Criteria

Babies whose parents specifically request that their baby does not contribute data or samples

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Proportion of babies exposed to antibiotics measured using Antibiotic Use Questionnaire conducted at four survey timepoints through the 25-day duration of the study defined by the site team<br>2. Prevalence of resistant bacterial colonisation measured using Colonisation Questionnaire and stool and skin swab sample collection, conducted at four survey timepoints through the 25-day duration of the study defined by the site team

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures