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Studying infection prevention methods for infants admitted to neonatal hospital units

NeoIPC unit-level resistant bacterial colonisation surveillance

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN16979943
Enrollment
31
Registered
2023-08-01
Start date
2021-10-01
Completion date
Unknown
Last updated
2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Sponsors

PENTA Foundation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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). ? 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

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

Design outcomes

Primary

MeasureTime frame
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 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

MeasureTime frame
There are no secondary outcome measures

Countries

England, Estonia, Germany, Greece, Italy, Poland, South Africa, Spain, Switzerland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026