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

NeoDECO trial is a cluster-randomised study involving up to 24 neonatal units (clusters) across five European countries: Switzerland, Italy, Greece, Spain, and the United Kingdom. Each participating neonatal unit constitutes a cluster, with the intervention implemented at the unit level. The study is structured into two staggered. Within each stagger, sites are randomised 1:1 to either the intervention arm or control arm (standard care).

Control Arm (Standard Care): Sites randomised to the control arm will continue with current routine practices, which might include kangaroo care (KC), skin-to-skin contact (StSC), infection prevention and control measures, and the treatment of severe infections or neonatal sepsis. While KC is already part of routine care in all participating units, there are no structured efforts in place to ensure adherence to international best practice guidelines.

Intervention Arm (Optimised KC): Sites in the intervention arm will implement optimised KC in line with internationally recognised best practice recommendations. The intervention is comprised of two key components:

Component 1: Skin-to-Skin Contact (StSC) for Optimised KC This component defines the desired frequency, duration, and initiation timing of early, repeated, and sustained StSC that characterise optimised KC in high-technology neonatal environments where KC is already offered.

Component 2: Implementation Support This component focuses on engaging clinical staff responsible for KC delivery. Implementation support includes training, ongoing support, and tools to embed optimised KC into routine practice. The goal is to facilitate sustained practice change through staff empowerment and structured implementation strategies.

Following randomisation, sites allocated to the intervention arm will undergo an intervention period of up to 10 months. All sites-regardless of allocation-will collect clinical data and biological samples from all consented high-risk infants present in the unit on the day of the assessment. The collected samples will be analyzied centrally and help monitor colonisation and infection patterns over time, with particular focus on the incidence of hospital-acquired infections.

To evaluate the fidelity and quality of the intervention delivery, one representative intervention site from each participating country will be selected for enhanced data collection and engagement with the implementation team. These sites will participate in more detailed assessments related to: fidelity of intervention delivery, implementation strategies used, acceptability, appropriateness, and feasibility of optimised KC.

At the conclusion of the study, all control sites will receive full support and training to implement optimised KC using the tested implementation strategies. This ensures equitable access to the intervention benefits across all participating units and supports the potential scale-up of optimised KC practices beyond the trial period.

• Resistant bacterial colonisation defined as the detection of one or more pre-specified bacterial resistance genes in a stool sample during a PPS [Time frame: 12 months]
• Surveillance-based neonatal severe infection/sepsis based on cluster-aggregated NeoIPC Surveillance data. [Time frame: 12 months]
• Infection outcomes assessed with separate cumulative incidences of the three components of the primary outcome and necrotising enterocolitis [Time frame: 12 Months]
• Infection outcomes defined with incidence rate number [Time frame: 12 Months]
• Major non-infection neonatal morbidity collected aggregated at the cluster level, separately for the baseline and intervention period, and is therefore a unit-level endpoint [Time frame: 12 months]
• Neonatal unit length of stay: total number of calendar days an infant was hospitalised on the neonatal unit during the study period [Time frame: 12 months]
• Antibiotic treatment recording through both NeoIPC Surveillance and clinical data collection in PPS [Time frame: 12 months]
• StSC duration in hours and minutes in the preceding 24 hours [Time frame: 12 months]
• StSC target attainment: the minimum expected target duration of StSC is a site-specific total daily duration of StSC to be provided per infant per day [Time frame: 12 months]