Periodic Reporting for period 1 - 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: 2021-04-01 al 2022-09-30
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. Twelve 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. Twelve 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 first period of NeoIPC has focused on various activities to achieve its goals. Key project management tasks were completed to enable all the partners to work well together. To support research in a vulnerable population, an independent ethical advisor was appointed who provides feedback on our activities. We also set up a website to stay in touch with neonatal units and the wider community.
In preparation for the trial, we engaged with 28 neonatal units to find out more about their current state of IPC. For this, we asked each unit to (i) complete a questionnaire about how they deal with IPC (ii) collect information on antibiotic use (iii) collect information and samples to look at resistant bacterial colonization in the unit. Both the data and samples gathered and finding the best way to collect them are important for trial planning.
In brief, responding neonatal units are very diverse with variable IPC approaches, offering considerable room for improvement. Information on patient management with an IPC dimension currently not considered a standard element of lPC showed that kangaroo care (skin to skin contact between babies and their mothers/other carers for a prolonged period, often several hours) was widely offered, but often not according to agreed best practice. About one third of the babies were from the highest risk group <32 weeks’ gestational age. The data confirm that these units care for babies at highest risk of resistant bacterial colonization. Antibiotic utilization in participating units was expectedly high and the use of multiple antibiotics, including broad-spectrum agents to treat resistant bacteria, was common. All sites considered the proposed approach for collecting data and samples to look at resistant bacterial colonization feasible, and acceptable to clinical staff and parents. The microbiological analysis of the samples is on-going.
In parallel, the implementation science team gathered information on IPC education needs. More targeted and consistent IPC engagement in neonatal care as well as evaluation and, if effective, implementation of interventions specific to this care setting are required. Any intervention tested in as large a trial should be deemed highly relevant and feasible by clinical staff. A literature review as well as the regulatory landscape cast doubt on the originally targeted intervention, antiseptic body washing. Clinical staff focus groups confirmed reservations towards this intervention. Instead, there was considerable interest in evaluating the potential effectiveness for IPC of optimization of current best practice measures, most importantly a full assessment of optimized skin to skin contact as an IPC intervention. This intervention is already supported by indirect evidence for an important effect on neonatal infection.
The interactions within the consortium and with neonatal units across Europe were harnessed to identify CPN steering board members representing multiple disciplines from 7 countries. The CPN will host workshops and webinars, will make open access materials on neonatal IPC available and will be a channel for disseminating NeoIPC outputs.
Surveillance will be modelled on the successful German NeoKISS module. Pros and cons of available data collection systems have been considered, including transferability to low- and middle-income countries and data privacy. DHIS2, an open source health information management, has been selected as the optimal tool. A protocol has been developed including all relevant targets. Testing of this tool is on-going and will inform modifications of the forms and protocol based on user feedback.
In preparation for the trial, we engaged with 28 neonatal units to find out more about their current state of IPC. For this, we asked each unit to (i) complete a questionnaire about how they deal with IPC (ii) collect information on antibiotic use (iii) collect information and samples to look at resistant bacterial colonization in the unit. Both the data and samples gathered and finding the best way to collect them are important for trial planning.
In brief, responding neonatal units are very diverse with variable IPC approaches, offering considerable room for improvement. Information on patient management with an IPC dimension currently not considered a standard element of lPC showed that kangaroo care (skin to skin contact between babies and their mothers/other carers for a prolonged period, often several hours) was widely offered, but often not according to agreed best practice. About one third of the babies were from the highest risk group <32 weeks’ gestational age. The data confirm that these units care for babies at highest risk of resistant bacterial colonization. Antibiotic utilization in participating units was expectedly high and the use of multiple antibiotics, including broad-spectrum agents to treat resistant bacteria, was common. All sites considered the proposed approach for collecting data and samples to look at resistant bacterial colonization feasible, and acceptable to clinical staff and parents. The microbiological analysis of the samples is on-going.
In parallel, the implementation science team gathered information on IPC education needs. More targeted and consistent IPC engagement in neonatal care as well as evaluation and, if effective, implementation of interventions specific to this care setting are required. Any intervention tested in as large a trial should be deemed highly relevant and feasible by clinical staff. A literature review as well as the regulatory landscape cast doubt on the originally targeted intervention, antiseptic body washing. Clinical staff focus groups confirmed reservations towards this intervention. Instead, there was considerable interest in evaluating the potential effectiveness for IPC of optimization of current best practice measures, most importantly a full assessment of optimized skin to skin contact as an IPC intervention. This intervention is already supported by indirect evidence for an important effect on neonatal infection.
The interactions within the consortium and with neonatal units across Europe were harnessed to identify CPN steering board members representing multiple disciplines from 7 countries. The CPN will host workshops and webinars, will make open access materials on neonatal IPC available and will be a channel for disseminating NeoIPC outputs.
Surveillance will be modelled on the successful German NeoKISS module. Pros and cons of available data collection systems have been considered, including transferability to low- and middle-income countries and data privacy. DHIS2, an open source health information management, has been selected as the optimal tool. A protocol has been developed including all relevant targets. Testing of this tool is on-going and will inform modifications of the forms and protocol based on user feedback.
So far, NeoIPC represents the largest European network of neonatal units dedicated to IPC. Through the engagement of >50 units and integration of all work packages the consortium was able to rapidly assess its planned activities, identifying areas requiring modification but also affirming the overall project approach. All sites and partners express strong support for investigating an IPC intervention tailored to neonatal care for its baby- and unit-level effects in a cluster randomised controlled trial (cRCT). Once initiated the trial will be among the largest neonatal cRCTs in Europe. Preliminary data have been collected on >500 babies in 15 neonatal units to date, a number expected to double in early 2023. These will provide a detailed picture of current IPC practices, risk factors for resistant bacterial colonization and resistant bacterial prevalence in units across Europe. The high interest of sites is reflected in the steady progress in bringing together a CPN specifically focused on neonatal IPC.
Several results and associated impacts are expected until the end of the project: 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 the area of 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 until the end of the project: 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 the area of IPC and a platform for future pragmatic hybrid implementation-effectiveness trials with rapid translation from research into practice.