NeoDeco, part of the Horizon 2020-funded NeoIPC project (n. 965328) and sponsored by Fondazione Penta ETS, is a cluster randomised hybrid effectiveness-implementation study, starting in 2024. It aims to assess whether the implementation of an optimised skin-to-skin contact reduces neonatal severe infection and resistant bacterial colonisation among infants born <32 weeks' gestation, defined as high-risk, in neonatal intensive care units (NICUs). A 4-week feasibility study assessing unit-level resistant colonisation preceded NeoDeco in 14 European sites in 2022-2023.

Resistant bacterial colonisation (detection of minimum one of the following genes via PCR in a stool sample: VanA, VanB, blaKPC, blaNDM, blaVIM, blaIMP, blaOXA-48, blaCTX-M group1, blaCTX-M group9) outcomes were measured using cross-sectional surveys of stool samples. Colonisation data were captured using REDCap.

Overall, 753/934 infants contributed stool samples (181 not producing stools) in 56 surveys, 333 being high-risk. Of the 42/56 surveys with any resistant bacteria colonisation, the median of colonised infants per survey was 28% (IQR 15%-56%), with a median of 3 infants colonised (IQR 2-7). A median of 45% (IQR 30%-58%) of colonised infants per survey were high-risk (median=2 infants (IQR 1-3), Figure 1. The resistant bacterial colonisation prevalence, overall and in high-risk infants, varied by site, being higher in southern Europe.

NeoDeco will soon run in 24 NICUs in 5 countries (Greece, Italy, Spain, Switzerland, United Kingdom). The effectiveness outcomes measured in high-risk infants will be cumulative incidence of hospital-acquired sepsis and unit-level resistant bacterial colonisation, applying the same pragmatic approaches to data collection and monitoring, that could be implemented and used for wider applications.