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

NeoDeco is a pragmatic, multicenter, parallel-group, cluster-randomised hybrid effectiveness-implementation trial designed to evaluate the impact of implementing optimised Kangaroo Care (KC) at the unit level compared to standard care in high-technology neonatal units. The trial includes a baseline period, a wash-in phase, and a staggered randomisation approach. The primary focus of the NeoDeco study is on high-risk preterm infants born at less than 32 weeks' gestational age, a population particularly vulnerable to hospital-acquired infections and sepsis during their initial hospital stay. By investigating hospital-acquired infections specifically, the study targets the period during which optimised KC practices are likely to have the most significant impact.

NCT Number	NCT05993442
Lead Sponsor	PENTA Foundation Collaborators: European Clinical Research Alliance for Infectious Diseases (ECRAID), University of Zurich, Universiteit Antwerpen, Charite University, Berlin, Germany, UMC Utrecht, Swiss Tropical & Public Health Institute, St George's, University of London
Conditions	Infection, Bacterial, Infection Prevention
Enrollment	3,080 participants
Start Date	2024-05-28
Primary Completion	2026-04 (estimated)
Study Completion	2026-05 (estimated)
Updated on ClinicalTrials.gov	2026-03-25