The NeoDeco study, led by Fondazione Penta EST, is creating an impact in neonatal care. This innovative study investigates whether optimised kangaroo care can reduce severe infections, sepsis, and resistant bacterial colonisation in high-risk newborns. The goal is to see if skin-to-skin contact between infants and caregivers, when done optimally, can prevent life-threatening infections in neonatal intensive care units (NICUs).
The study targets infants born before 32 weeks of gestation. These babies are highly vulnerable due to their immature immune systems and lengthy stays in NICUs. Neonatal sepsis and antibiotic-resistant infections are major threats to their health. If the NeoDeco study proves successful, it could revolutionise neonatal care and offer a safe and low-cost solution to prevent infections and antibiotic resistance in NICUs worldwide.
Progress so far
The first infant was enrolled on June 1st of this year, marking the start of the study. As of October 3rd, 10 NICUs in Greece and Switzerland are actively enrolling and 142 infants have already been recruited. The study will include 24 high-tech NICUs across 5 countries in Europe.
Colonisation point prevalence surveys (PPS) will be conducted throughout the study. During weekly PPSs, colonisation samples (stool samples) and basic clinical data are collected. After three months, sampling of stool will continue every four weeks, while collection of basic clinical data will remain on a weekly basis. Data collected during the first three months, will be used to determine which NICUs will be assigned to either the kangaroo care arm or the routine care arm.
LAB-Net’s central role
LAB-Net plays an essential role in the NeoDeco study as the central laboratory. We are responsible for analysing the stool samples collected from infants to detect resistant bacterial colonisation. LAB-Net uses RT-PCR (real-time polymerase chain reaction) testing to determine the presence of resistance genes in the samples.
LAB-Net’s work is well underway. RT-PCR tests are being performed on samples from the first four surveys at each active site. These results will inform the randomisation process between the kangaroo care and routine care arms.
LAB-Net’s responsibilities not only include sample analysis. We also support the participating NICUs during the collection, storage and shipping of samples. LAB-Net developed the sample collection and management manual, trained staff at participating NICUs on the sample collection and management aspects, and provided all the materials needed for sample collection and storage. LAB-Net also monitors sample registration, coordinates the shipment of samples to its central laboratory and performs sample reconciliation upon arrival.
Our work continues as the study progresses. Next steps are training the remaining NICUs, (re-)supplying materials to the sites, managing sample shipments, and performing RT-PCR analyses on all collected stool samples. Of course, we also make sure that the samples are biobanked for future research.
Looking ahead
The NeoDeco study represents a significant opportunity to enhance neonatal care, particularly for high-risk infants in NICUs. LAB-Net is glad being a part of this study, as conclusions could have a tremendous impact on the routine care of high-risk infants in NICUs. Good quality samples and analysis are crucial for making correct conclusions. Therefore, we also want to thank all sites involved in this study for their work in making this happen.
Within NeoDeco, we will conduct a number of sub-studies to learn more about the transmission routes of bacteria in NICUs by investigating the presence of resistant bacteria on surfaces in the environment. We will also look in environmental and infant samples for the existence of resistance to biocides. Biocides like antiseptics and disinfectants are antimicrobial agents that are commonly used during IPC measures. Finally, we aim to investigate the microbiological impact of kangaroo care on the infant by examining the bacteria present on the infant (skin and stool samples) and comparing them with those present on the caregiver (skin and stool samples).
NeoDeco is part of the NeoIPC project: Establishing innovative approaches for optimal infection prevention of resistant bacteria in NICUs by integrating research, implementation science and surveillance in a sustainable global platform. As preparation for the NeoDeco study, University of Antwerp was responsible of establishing sampling and analytical protocols to be utilised within the Colonization assessment phase as well as the NeoDeco trial. During the Colonisation assessment feasibility study, 24 sites collected skin swabs and stool samples from all infants in the NICU on the day of sampling during 4 weekly PPS. University of Antwerp was responsible for shipping sample kits to and collected samples from the site, and analyzing the collected skin swabs and stool samples.