NeoDeco

Every year, around 400,000 babies in Europe are born preterm and require admission to a neonatal intensive care unit (NICU). While neonatal intensive care greatly improves their chances of survival, it also exposes babies to antibiotic-resistant bacteria from the hospital environment. These bacteria can lead to severe infections, sepsis and outbreaks of disease, posing significant risks in the fragile NICU environment.
The NeoDeco study aims to determine if optimised kangaroo care can reduce resistant bacterial colonization, severe neonatal infections and sepsis in preterm infants in NICUs. The goal is to see if this simple and low-cost practice, when applied at an optimal level, can effectively prevent infections and the spread of resistant bacteria in NICUs.

The Study

NeoDeco is a pragmatic, multicentre, parallel group, cluster randomised hybrid effectiveness-implementation study, conducted in 24 NICUs across 5 European countries (Greece, Italy, Spain, Switzerland, United Kingdom). The population of interest consists of high-risk infants, ie. infants born before 32 weeks’ gestational age, hospitalised in high-technology European neonatal intensive care units during the study period.
After a baseline period, in which NICUs collect data on bacterial colonisation levels while employing current standard care practices, randomisation will occur, with allocation to either the intervention arm or the standard care arm. Sites allocated to the intervention arm will implement optimised kangaroo care (defined as early, repeated and sustained skin-to-skin contact) and will be offered tailored implementation support to ensure they adhere to the levels of kangaroo care required by the study. Control sites will continue to offer standard care.

All sites will collect data on high-risk infants in the neonatal unit through NeoIPC surveillance. They will also collect stool samples and clinical data for all high-risk infants. After the baseline period, stool sampling will be reduced to once every four weeks, but clinical data collection will continue weekly. 

At the end of the intervention period, all controls sites will be supported and trained to implement optimised kangaroo care, using selected implementation strategies.

Read more about the study here.

Partners

The NeoDeco study is sponsored by Fondazione Penta ETS (Italy). Ecraid is part of the study management group and is responsible for site management, Trial Master File (TMF) maintenance, arranging investigator meetings, monitoring, and coordination of close-out visits. 

NeoDeco is part of the NeoIPC project, which is coordinated by the University of Padova (Italy). NeoIPC has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 965328.