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.

What this Trial Is About

The NeoDeco trial investigates the impact of optimised Kangaroo Care (KC) on reducing severe infections, sepsis, and resistant bacterial colonisation in high-risk preterm infants born before 32 weeks' gestation. This pragmatic, multicenter, cluster-randomised study focuses on neonatal intensive care units (NICUs) across several European countries, aiming to assess KC practices during the critical initial hospital stay when infants are vulnerable to hospital-acquired infections. The study compares two groups of neonatal units: those continuing standard care, which includes routine KC and infection prevention measures, and those implementing optimised KC based on international best practice guidelines. Optimised KC involves two main components: enhanced skin-to-skin contact with defined frequency, duration, and initiation timing, and structured implementation support including staff training and engagement. After randomisation, the intervention period lasts up to 10 months, with all sites collecting clinical data and biological samples from eligible infants. Participants include high-risk infants admitted to participating NICUs, with ongoing monitoring of infection incidence, bacterial colonisation, and treatment outcomes. Data collection includes surveillance of skin-to-skin contact duration, infection rates, antibiotic use, and neonatal morbidity. Selected intervention sites undergo detailed assessment of implementation fidelity and feasibility. The study concludes by offering optimised KC training to all control sites, promoting wider adoption of best practices beyond the trial.

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