Periodic Reporting for period 2 - NeoIPC (Establishing innovative approaches for optimal infection prevention of resistant bacteria in NICUs by integrating research, implementation science and surveillance in a sustainable global platform)
Periodo di rendicontazione: 2022-10-01 al 2024-03-31
NeoIPC is designed to work out the best way to protect babies who need to stay in hospital after being born from being infected by resistant bacteria.
At least 5 of 100 babies in the world are born too early (preterm), and around 8 of 100 babies in Europe will need to be cared for in a neonatal unit. These babies are very vulnerable: They do not yet have an established mix of good bugs (bacteria) living in e.g. in the gut; They are exposed to a lot of antibiotics and medical devices; They are generally looked after in multi-cot bays, commonly resulting in transfer of bacteria between them.
Hospital bacteria are often difficult to treat and resistant to antibiotics typically used to treat neonatal infections. Treatment for a possible infection will be given to 1 in 3 babies on a neonatal unit during their hospital stay. Infections, especially if caused by resistant bacteria, carry a risk of dying but can also impact babies’ neurological development. We currently lack evidence on how to prevent resistant bacteria from being transferred to babies on neonatal units (called colonization), which happens before babies become ill.
NeoIPC focuses on investigating interventions and strategies that could be used to prevent resistant bacterial colonization of babies on neonatal units. Fourteen multidisciplinary partners are working to determine the best way to test, implement and measure the effect of such interventions. NeoIPC will also support the formation of a clinical practice network (CPN) of neonatal units to improve infection prevention and control (IPC) in neonatal care.
At least 5 of 100 babies in the world are born too early (preterm), and around 8 of 100 babies in Europe will need to be cared for in a neonatal unit. These babies are very vulnerable: They do not yet have an established mix of good bugs (bacteria) living in e.g. in the gut; They are exposed to a lot of antibiotics and medical devices; They are generally looked after in multi-cot bays, commonly resulting in transfer of bacteria between them.
Hospital bacteria are often difficult to treat and resistant to antibiotics typically used to treat neonatal infections. Treatment for a possible infection will be given to 1 in 3 babies on a neonatal unit during their hospital stay. Infections, especially if caused by resistant bacteria, carry a risk of dying but can also impact babies’ neurological development. We currently lack evidence on how to prevent resistant bacteria from being transferred to babies on neonatal units (called colonization), which happens before babies become ill.
NeoIPC focuses on investigating interventions and strategies that could be used to prevent resistant bacterial colonization of babies on neonatal units. Fourteen multidisciplinary partners are working to determine the best way to test, implement and measure the effect of such interventions. NeoIPC will also support the formation of a clinical practice network (CPN) of neonatal units to improve infection prevention and control (IPC) in neonatal care.
The project-specific NeoIPC framework has been established and can be considered mature by the end of the second period. This includes project management, communication and dissemination activities as well as regular involvement of an independent ethical advisor and a scientific advisory board.
During the first period, kangaroo care (skin to skin contact between babies and their mothers/other carers for a prolonged period, often several hours) was identified as the intervention most likely to be of interest. Any intervention tested in as large a trial should be deemed highly relevant and feasible by clinical staff. Kangaroo care is already supported by indirect evidence for an important effect on neonatal infection.
Analysis of information gathered during the first period was completed and incorporated into the protocol of the main study (NeoDeco). This includes feedback from neonatal units about their current state of IPC, antibiotic use and resistant bacterial carriage. In brief, we have been able to confirm that better kangaroo care is the critical intervention for neonatal units to consider. Furthermore, strong consistency of the level of carriage of resistant bacteria in participating units has enabled us to refine how we will look at the effect of kangaroo care on this.
The NeoDeco trial will investigate whether better kangaroo care practiced at the unit-level (meaning offered to all babies for whom this is relevant in a given neonatal unit) reduces the rate at which babies in the unit are affected by infection needing antibiotic treatment. The trial will also test what can be done to help units improve offering kangaroo care by developing and evaluating so-called implementation strategies. In total, 24 neonatal units taking part in this trial will be sufficient to measure an effect that is important to babies, their families and healthcare providers. Importantly, neonatal units will be allocated by chance (randomised) to either continuing to do current levels of IPC and kangaroo care or to engaging with the above-mentioned implementation strategies to improve kangaroo care. This will make it possible for us to fairly compare the added benefit (if any) of kangaroo care on infections.
All activities required to find and set up neonatal units taking part in the trial have been completed. NeoDeco will involve units from Greece, Italy, Spain, Switzerland and the United Kingdom with a very diverse profile in terms of size and structure as well as with different approaches to neonatal IPC and kangaroo care. The units have been interacting with the implementation, surveillance and microbiology teams represented in the project to make sure that the trial protocol and procedures are suitable and that all units have a clear understanding of what will be happening in the trial.
In terms of communication and outreach, we have been monitoring engagement through the NeoIPC website and social media, as well as initiating and consolidating interactions with a wide range of groups, societies and professional bodies that are likely to find our work relevant.
The clinical practice network has continued to expand. CPN steering board members representing multiple disciplines from 7 countries have further developed the planned activities and engagement strategy, including hosting of workshops and webinars, provision of open access materials on neonatal IPC through the website and establishing a pathway towards disseminating NeoIPC outputs.
During the first period, kangaroo care (skin to skin contact between babies and their mothers/other carers for a prolonged period, often several hours) was identified as the intervention most likely to be of interest. Any intervention tested in as large a trial should be deemed highly relevant and feasible by clinical staff. Kangaroo care is already supported by indirect evidence for an important effect on neonatal infection.
Analysis of information gathered during the first period was completed and incorporated into the protocol of the main study (NeoDeco). This includes feedback from neonatal units about their current state of IPC, antibiotic use and resistant bacterial carriage. In brief, we have been able to confirm that better kangaroo care is the critical intervention for neonatal units to consider. Furthermore, strong consistency of the level of carriage of resistant bacteria in participating units has enabled us to refine how we will look at the effect of kangaroo care on this.
The NeoDeco trial will investigate whether better kangaroo care practiced at the unit-level (meaning offered to all babies for whom this is relevant in a given neonatal unit) reduces the rate at which babies in the unit are affected by infection needing antibiotic treatment. The trial will also test what can be done to help units improve offering kangaroo care by developing and evaluating so-called implementation strategies. In total, 24 neonatal units taking part in this trial will be sufficient to measure an effect that is important to babies, their families and healthcare providers. Importantly, neonatal units will be allocated by chance (randomised) to either continuing to do current levels of IPC and kangaroo care or to engaging with the above-mentioned implementation strategies to improve kangaroo care. This will make it possible for us to fairly compare the added benefit (if any) of kangaroo care on infections.
All activities required to find and set up neonatal units taking part in the trial have been completed. NeoDeco will involve units from Greece, Italy, Spain, Switzerland and the United Kingdom with a very diverse profile in terms of size and structure as well as with different approaches to neonatal IPC and kangaroo care. The units have been interacting with the implementation, surveillance and microbiology teams represented in the project to make sure that the trial protocol and procedures are suitable and that all units have a clear understanding of what will be happening in the trial.
In terms of communication and outreach, we have been monitoring engagement through the NeoIPC website and social media, as well as initiating and consolidating interactions with a wide range of groups, societies and professional bodies that are likely to find our work relevant.
The clinical practice network has continued to expand. CPN steering board members representing multiple disciplines from 7 countries have further developed the planned activities and engagement strategy, including hosting of workshops and webinars, provision of open access materials on neonatal IPC through the website and establishing a pathway towards disseminating NeoIPC outputs.
So far, NeoIPC represents the largest European network of neonatal units dedicated to IPC. Through the engagement of >100 units and reach out to multiple societies and professional bodies, the visibility of neonatal IPC has been increased. As an example, consortium members have been invited to present NeoIPC activities and findings at several international conferences. NeoDeco, investigating an IPC intervention tailored to neonatal care for its baby- and unit-level effects in a cluster randomised controlled trial (cRCT), was met with strong international support. Upon initiation early in the third period, the trial will be among the largest neonatal cRCTs in Europe and globally. Preliminary data have been collected on 1073 babies in 24 neonatal units to date and have been instrumental in planning trial activities. Furthermore, unexpected findings, such as a high contribution of resistant bacterial carriage by non-high-risk babies to overall unit-level resistant bacterial carriage, confirm the need to better understand how IPC needs to be addressed in neonatal care. The high interest of sites is reflected in the steady increase in the number of units engaging in the CPN specifically focused on neonatal IPC.
Several results and associated impacts are expected: NeoIPC will provide a framework and platform for conducting research on neonatal IPC and for implementing effective interventions. 24 trial units and more non-trial units are expected to engage in the CPN facilitating rapid sharing of findings and experience. The trial will investigate a neonatal care-specific intervention likely to reduce resistant bacterial infection in settings where prevalence of resistant infections is high. The intervention will be relevant globally, benefitting local neonates and diminishing resistant bacterial spread. Cost-effectiveness will be assessed in terms of impact on mortality and healthcare-associated costs, but also neonatal infection-associated poor neurological development and thus long-term morbidity. NeoIPC will therefore generate important insights into low-cost effective measures to reduce the impact of resistant bacterial infection on neonatal care, bringing together a network of neonatal units jointly working in IPC and a platform for future pragmatic hybrid implementation-effectiveness trials with rapid translation from research into practice.
Several results and associated impacts are expected: NeoIPC will provide a framework and platform for conducting research on neonatal IPC and for implementing effective interventions. 24 trial units and more non-trial units are expected to engage in the CPN facilitating rapid sharing of findings and experience. The trial will investigate a neonatal care-specific intervention likely to reduce resistant bacterial infection in settings where prevalence of resistant infections is high. The intervention will be relevant globally, benefitting local neonates and diminishing resistant bacterial spread. Cost-effectiveness will be assessed in terms of impact on mortality and healthcare-associated costs, but also neonatal infection-associated poor neurological development and thus long-term morbidity. NeoIPC will therefore generate important insights into low-cost effective measures to reduce the impact of resistant bacterial infection on neonatal care, bringing together a network of neonatal units jointly working in IPC and a platform for future pragmatic hybrid implementation-effectiveness trials with rapid translation from research into practice.