Ecraid joins study on reducing infections in NICUs through kangaroo care

The European multicenter study NeoDeco will investigate whether optimised kangaroo care can reduce infection rates in preterm babies in neonatal intensive care units (NICUs). Over the next two years, the study will include 24 NICUs in 5 European countries. It is sponsored by Fondazione Penta ETS (Padova, Italy) and conducted as part of the EU-funded NeoIPC project, coordinated by the University of Padova.

Ecraid is responsible for various tasks of crucial importance during the study's recruitment phase. Our team is doing site management, Trial Master File (TMF) maintenance, arranging investigator meetings, monitoring, and coordination of close-out visits.

Clinical microbiologist and epidemiologist Elske Sieswerda, who is NeoDeco's coordinating investigator, explains the importance of the study:

Premature infants, especially those born extremely early, face a high risk of sepsis. The worldwide rapid increase in antibiotic resistance is particularly concerning for this vulnerable population. With the innovative trial design of NeoDeco, which includes implementation science methods, we will gather robust data on the effects of Kangaroo Care implementation on risk of sepsis and resistant bacterial colonisation in premature infants across Europe. We will additionally learn how best to implement such a behavioural intervention at the neonatal unit level. Our intervention may increase the chances of long-term healthy development of prematurely born infants in the era of bacterial resistance. We therefore hope that the results of NeoDeco will transform neonatal care practices in Europe and beyond.

Kangaroo care

Every year, around 400,000 babies in Europe are born preterm and require admission to a NICU. While neonatal intensive care greatly improves their chances of survival, it also exposes these vulnerable babies to antibiotic-resistant bacteria from the hospital environment. These bacteria can lead to severe infections, sepsis, and even outbreaks of disease, posing significant risks in the fragile NICU environment.

For premature newborns, the World Health Organization recommends kangaroo care: a simple, safe and low-cost practice that involves prolonged skin-to-skin contact between the baby and their caregiver. Kangaroo care is thought to help babies acquire more healthy bacteria, which can boost the development of their immune systems.

Despite its benefits, the broader impact of kangaroo care on preventing transmission of antibiotic-resistant bacteria and reducing NICU infections is still underexplored. “Comprehensive studies on the effects of kangaroo care on neonatal infections caused by difficult to treat bacteria at NICU-wide level are currently lacking”, notes Julia Bielicki, Senior Researcher at the Centre for Neonatal and Paediatric Infection of St George’s, University of London (United Kingdom) and NeoDeco Chief Investigator.

NeoDeco

"NeoDeco’s objectives extend beyond examining kangaroo care's impact on individual babies. Our focus is to evaluate its potential as an infection prevention and control measure, when applied to most babies in an optimal and sustainable manner by NICUs", Bielicki adds.

“Optimised” kangaroo care is defined as early, repeated and sustained skin-to-skin contact, following international best practice recommendations. While some European NICUs already practice kangaroo care, the extent of its implementation varies widely in terms of how early, how often, and how long it is practiced.
To ensure that NICUs adhere to the optimal levels of kangaroo care required by the study, a team of implementation scientists from the University of Zurich will provide tailored site-level support, developing and tracking various implementation strategies.

Lauren Clack, Professor of Implementation Science in Health Care at the University of Zurich (Switzerland) and head of the implementation science team, explains: “Kangaroo care is a behavioural intervention, and as such it comes with its own set of challenges, such as beliefs or preferences of both parents and healthcare professionals. Our team will work closely with NICU staff to identify barriers to its optimal adoption and develop strategies together to effectively overcome them.”

“If successful, NeoDeco will not only contribute to validate the health benefits of kangaroo care but could also establish a new standard of care to improve preterm birth outcomes across Europe, ensuring a healthier start for this vulnerable population”, states Carlo Giaquinto, Professor of Paediatrics at the University of Padova (Italy), and President of Fondazione Penta ETS.

NeoDeco will begin in June 2024 for an initial group of NICUs from Greece and Switzerland. Neonatal units from Italy, Spain and the United Kingdom will start the study procedures in the second half of 2024. The study will run for two years and results will be available in 2026.

For more information, visit neoipc.org.