Clinical trial NCT05993442: Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU.
Official title: Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in Neonatal Intensive Care: a Pragmatic, Multicentre, Parallel Cluster Randomised Hybrid Implementation-effectiveness Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infection, Bacterial
Keywords: Nosocomial Infection
Prevention
Bacterial
Cluster
Implementation science
Surveillance
Neonatal unit
Lead sponsor: PENTA Foundation
Sponsor class: NETWORK
Collaborators: name: St George's, University of London
name: European Clinical Research Alliance for Infectious Diseases (ECRAID)
name: University of Zurich
name: Universiteit Antwerpen
name: Charite University, Berlin, Germany
name: UMC Utrecht
name: Swiss Tropical & Public Health Institute
First posted: 2023-08-15
Enrollment: 3080
Sex: ALL
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 be offered the implementation support for optimised Kangaroo Care (KC) as part of the study; however, intervention sites will be randomised to immediate receipt of implementation support whereas standard care sites will be offered this after the study period.

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 two staggered phases (with at least 10 sites in each). Within each stagger, sites will be randomized to either the intervention arm or the control arm (standard care). Randomisation will occur at the end of the baseline period, which will be identical for all sites. Intervention sites will then undergo a 2-month wash-in phase during which they will receive training and workshops on implementation strategies for optimized Kangaroo Care (KC). Each neonatal unit/site constitutes a cluster, and the intervention is applied at the unit level.

Following the wash-in phase, the intervention period for intervention sites will last 10 months. During this time, optimised KC-defined as early, repeated, and sustained skin-to-skin contact-will be continuously implemented.

All sites, regardless of their allocation (intervention or control arm), will conduct a baseline data collection phase involving clinical surveillance and colonisation assessments. This includes data and sample collection for all consented high-risk babies present in the unit on the day of assessment. Specifically, all sites will collect stool samples weekly during the baseline period and monthly during the wash-in and intervention periods from all high-risk babies present in the unit on the day of the assessment.

Additionally, one representative site per country from the intervention arm will be selected for further in-depth engagement and data collection by the implementation team. This will gather additional information on intervention fidelity and implementation strategies, including acceptability, appropriateness, feasibility, and sustainability.

At the end of the intervention period, all control sites will be supported and trained to implement the optimised KC using the selected implementation strategies.

Eligibility criteria: 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:

Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Neonatal severe infection/sepsis
timeFrame: 12 months
measure: Resistant bacterial colonisation over time
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of neonatal sever infections
timeFrame: 12 months
measure: Incidence of neonatal morbidity
timeFrame: 12 months
Other outcomes:
measure: Incidence of SSIs
timeFrame: 12 months
measure: Prevalence of breastfeeding
timeFrame: 12 months
measure: Incremental cost-effectiveness ratio (ICER)
timeFrame: 12 months
measure: Budget impact of the intervention arm
timeFrame: 12 months
Locations:
city: Attikí
country: Greece
facility: University General Hospital Attikon
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
city: Ioánnina
country: Greece
facility: Ioannina University Hospital
city: Thessaloniki
country: Greece
facility: Hippokration Hospital - Thessaloniki
city: Thessaloníki
country: Greece
facility: Papageorgiou Hospital
city: Basel
country: Switzerland
facility: University of Basel Children's Hospital
city: Bern
country: Switzerland
facility: Inselspital - University Hospital of Bern
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Saint-Gall
country: Switzerland
facility: Children's Hospital of Eastern Switzerland St.Gallen
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich - University Hospital Zurich
Study officials:
affiliation: St George's, University of London
name: Julia Bielicki, PhD
role: STUDY_CHAIR
References: