Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU. (NeoDeco)

PENTA Foundation

Status: Enrolling

Conditions: Infection, Bacterial

Treatments: Behavioral: Optimised kangaroo care

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT05993442

NeoDeco

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,080 estimated patients

Sex: All

Ages: 28 to 36 weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,080 participants in 2 patient groups

Optimised kangaroo care

Experimental group

Description:

The sites randomised in this group will adapt the study intervention consisting of: Component 1: Skin-to-skin contact for optimised KC, describes the targeted level of early, repeated and sustained skin-to-skin contact (StSC) considered to represent optimised KC in a high-technology neonatal unit environment in which KC is already offered as part of routine care. Component 2: Implementation Support aims to engage clinical staff in the neonatal unit who are involved in implementing StSC as part of optimised KC.

Treatment:

Behavioral: Optimised kangaroo care

Standard of Care

No Intervention group

Description:

The sites randomised in this group will follow the standard care, including KC and StSC sessions, treatment of severe infections/sepsis and infection prevention and control measures based on current routine local practice. Standard care in all participating NICUs already includes KC but without specific activities to ensure this is implemented according to international best practice recommendations.