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

Overview

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.

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.