Status:
RECRUITING
Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU.
Lead Sponsor:
PENTA Foundation
Collaborating Sponsors:
St George's, University of London
European Clinical Research Alliance for Infectious Diseases (ECRAID)
Conditions:
Infection, Bacterial
Eligibility:
All Genders
Up to 36 years
Phase:
NA
Brief Summary
NeoDeco is a pragmatic, multicenter, parallel group, cluster randomised hybrid effectiveness-implementation study with baseline assessment, wash-in period and staggered randomisation. All sites will b...
Detailed Description
The NeoDECO trial is a cluster-randomized trial involving up to 24 neonatal units across 5 European countries: Switzerland, Italy, Greece, Spain, and the United Kingdom. Sites will be grouped into tw...
Eligibility Criteria
Inclusion
- In NeoDeco there are no participant inclusion or exclusion criteria because this is a cluster randomised trial, so the intervention will be applied to all babies admitted to the neonatal intensive care unit as a cluster.
- However, the neonatal intensive care units will have to meet the following criteria to be involved in the study:
- European NICUs that provide routine care of extremely premature infants (\< 28 weeks' gestational age).
- Minimum number of 12 beds offering highest level of neonatal intensive care.
- Availability of or access to -70 to -80°C freezer for storage of research samples.
- Willing to implement optimised KC if allocated to the intervention group.
- Willing to commit to offering the minimum expected target duration or an increase of 50% if NICU is already offering the minimum expected target duration, if allocated to the intervention arm.
- Prepared to implement NeoIPC surveillance
- Adequate resources and expertise and approvals from relevant Research Ethics Committees, as appropriate.
Exclusion
- NICU already practices 'long-term' StSC of \> 18 hours. Major expected changes in resistant bacterial colonisation pressure during the study period, for example due to planned move to a new ward.
- Participation in other interventional IPC research projects which might directly influence the study intervention or outcome.
Key Trial Info
Start Date :
May 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
3080 Patients enrolled
Trial Details
Trial ID
NCT05993442
Start Date
May 28 2024
End Date
March 1 2026
Last Update
December 27 2024
Active Locations (10)
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1
University General Hospital Attikon
Attiki, Greece
2
University Hospital of Heraklion
Heraklion, Greece
3
Ioannina University Hospital
Ioannina, Greece
4
Hippokration Hospital - Thessaloniki
Thessaloniki, Greece