OUR MISSION Irish innovation in perinatal healthcare research leading the world: scientific excellence with societal and economic impact.
www.infantcentre.ie
@infantcentre www.facebook.com/infantcentre
Professor Louise Kenny Director Professor of Obstetrics and Gynaecology l.kenny@ucc.ie Professor Geraldine Boylan Director Professor of Neonatal Physiology g.boylan@ucc.ie Dr Anthony Morrissey Centre Manager anthony.morrissey@ucc.ie
INFANT is Ireland’s first dedicated perinatal research Centre. Founded upon over a decade of worldclass collaborative research and a diverse array of national and international academic and industry partnerships, INFANT is now an international leader of discovery and innovation in perinatal healthcare. INFANT addresses the largely unmet worldwide clinical need for effective screening tests for the most common complications of pregnancy and the most significant problems for newborn babies. Almost 1 in 5 pregnancies are complicated either by pre-eclampsia, spontaneous pre-term birth or fetal growth restriction. In half of the affected cases, the disease is so severe that serious maternal or perinatal morbidity or mortality can result. For the fetus, it is recognised that the short journey down the birth canal is one of the most dangerous. One in 20 newborns experience asphyxia at birth and may go on to develop brain injury and seizures.
INFANT: Innovation for the Next Generation
Although maternal and perinatal complications account for nearly 10% of the global burden of disease, R&D investment in perinatal health remains small and non-strategic; the number of registered pipeline drugs is only 1-5% of that for other major disease areas. It has been estimated that equitable industry R&D and public sector research funding in perinatal health over the next 10-20 years could avert 3% of the global disease burden. INFANT addresses this inequity. The creation of next generation devices to facilitate point-of-care and remote monitoring and diagnostics will transform antenatal and neonatal healthcare and service delivery on a global level and position Ireland at the fore in this field. Prevention of perinatal complications and adverse outcomes will have significant health economic impacts. Access to these world first technologies allows our industry partners to deliver innovative solutions to global markets, creating exciting and vast economic opportunities and delivering sustainable high knowledge value jobs in Ireland. Most importantly of all, INFANT will have fundamental societal impacts by changing the delivery of healthcare and improving outcomes for the most vulnerable members of our society - mothers and their babies.
Professor Louise Kenny (l.kenny@ucc.ie) Professor Geraldine Boylan (g.boylan@ucc.ie) Directors, INFANT (www.infantcentre.ie)
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The INFANT Biobank: INVESTING IN OUR FUTURE A not-for-profit perinatal biobank facility in Cork was established in 2008 to provide infrastructure for the €1.5million Health Research Board (HRB) Screening for Pregnancy Endpoints (SCOPE) study in Ireland. Since then, the biobank has expanded exponentially and is now home to over 1.5 million aliquots of biological samples from BASELINE www.baselinestudy.net, Ireland’s first and only birth cohort, BiHive www.medscinet.net/BIHIVE/ and most recently the €6million FP7 IMPROvED pregnancy cohort www.fp7-improved.eu/. The biobank is built upon the expertise of world-class database programmers, technicians and biobank curators who have pioneered the development of standard operating protocols for sample preparation, transport and storage of biological resources. The biobank adheres to the principles of the International Society for Biological and Environmental Repositories (ISBER) best practices, Molecular Medicine Ireland Guidelines for Standardised Biobanking, and OECD Guidelines for Human Biobanks and Genetic Research Databases. The protocols developed by INFANT are now acknowledged internationally as the gold standard for biobanking and the quality and integrity of patient data and samples underpinning the INFANT biobank have led to the development and validation of robust technologies and platforms for clinical use.
World class quality is the foundation for our innovation
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Biomarkers for Screening and Diagnostics in Pregnancy PREDICT to PREVENT: creating safer pregnancies for lifelong health Pre-eclampsia, fetal growth restriction and spontaneous preterm birth are the major complications of late pregnancy. They are leading causes of illness and death in mothers and newborn babies. In the developed world, in almost half the cases either the mother or baby require admission to an intensive care unit. Every year, an estimated $45 billion is spent on healthcare costs related to these pregnancy diseases. All three conditions can have lifelong consequences for the child. The child may have problems with brain development that can result in mild learning difficulties through to severe disabilities. Being born growth restricted predisposes the child to high blood pressure, heart attacks and diabetes as an adult. The social consequences and lifelong economic costs resulting from these conditions are enormous. Prevention of these health problems is of paramount importance to future mothers, fathers and children.
INFANT will develop early pregnancy screening tests that will offer accurate risk assessment for each disease. INFANT researchers have identified a number of potential clinical and molecular markers (certain proteins, fats and small molecules in blood) for these complications. None of these candidate markers are useful as individual predictive tests, but combinations of markers are likely to result in clinically useful screening tests. Further, recent advances in proteomic and metabolomic technologies and bioinformatics (advanced mathematics) allow us to discover and map differences in molecules circulating in the blood of women who later develop these conditions. This has created the opportunity to develop effective methods of predicting these diseases, with the potential to dramatically improve maternal and infant health worldwide.
Identification of first time mothers at risk for these conditions is the first step to effective intervention and prevention but, currently, there are no screening tests that accurately predict which first time mothers will develop these late pregnancy diseases.
The INFANT biomarker programme: prediction and prevention of the major diseases of late pregnancy, saving lives and delivering a healthier future for the next generation
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Innovative Cot-side Monitoring INFANT researchers aim to improve the long term health outcomes of newborn babies by early and accurate detection of neurological problems such as seizures and other adverse cerebral events. Early detection leads to prompt and appropriate treatments and intervention strategies. The team specialise in providing innovative solutions to commonly encountered problems in the Neonatal Intensive Care Unit (NICU) using enhanced real-time multi-modality physiological monitoring at the cot-side. We are developing algorithms with world-leading performance which can reliably and remotely monitor this complex physiological data, then accurately predict the onset of adverse events such as seizures in the brain, and assess the severity of such neurological problems. INFANT has developed unique platform technologies to examine the cellular and molecular mechanisms underlying brain injury in the newborn. We are examining the influence of genes regulating cell death following seizures, and the genomic and proteomic responses of the brain to such events. We have also developed experimental therapeutic models for the prevention of damage to the brain. Our platform technologies include in vitro and in vivo models, molecular biology, genomics/proteomics and imaging techniques. INFANT and our industry partners will thus deliver on the global unmet clinical need for embedded automated intelligence in neonatal patient monitoring devices. Our expertise in this field is based on a decade of multi-disciplinary research, where access to neonatal physiological data is a key factor.
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Translating World-Leading Perinatal Research into Commercial Healthcare Products
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Neonatal Risk Prediction One in every 50 babies born will need some form of resuscitation at birth and approximately 20% of those will suffer a significant lack of oxygen or blood supply to the brain and may develop severe conditions such as hypoxic-ischaemic encephalopathy (HIE). HIE remains an important cause of negative long term prognosis, with a high risk of learning disability, cerebral palsy, epilepsy, visual or hearing loss. There is an effective therapy, in the form of therapeutic hypothermia (cooling the baby), but to be effective it must be commenced within the first few hours after birth. The clinical need is for a fast and reliable way to identify which babies will need such treatment. INFANT is analysing at-birth blood biomarkers that will uniquely identify the at-risk babies and send them for early interventional strategies. We will then develop a point-of-care diagnostic test based on measurement of the relevant biomarkers in the delivery room. This world-first will help doctors to prevent brain injury and improve the baby’s chances of a normal survival, free from disability. Such innovations bring enormous commercial opportunities for the Irish MedTech sector.
Incubating ideas, delivering innovation
Prediction Detection Protection Prevention
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Protecting the Preterm Brain Up to 30% of extremely preterm infants are at risk of brain injury including haemorrhage and ischaemia, resulting in potentially lifelong consequences for the child. Protecting the preterm brain from injury is paramount. Whilst we have many ways of assessing how the heart and lungs are functioning, currently we have no simple way that allows us to confidently assess the health of the brain in preterms. INFANT will develop a cot-side device that provides the clinician with a continuous assessment of overall brain health in preterm infants. This device will incorporate many continuously obtained signals including brain electrical activity, oxygen levels and blood pressure. These measurements will be integrated using novel data algorithms to provide clinicians with an index of brain health for preterm infants. The ultimate goal is to have this become the standard of care in managing preterm babies in neonatal intensive care units worldwide.
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A global hub for data and biobanking
Perinatal Clinical Trials INFANT provides the platform for perinatal clinical trials and has a proven track record in global trial co-ordination, protocol development, study monitoring, secure data management, regulatory compliant databanking and biobanking processes, electronic database design and bioinformatics. The Centre operates to the highest ethical, quality and regulatory standards and is in partnership with the HRB-funded Clinical Research Facility in Cork. INFANT already hosts a number of international perinatal clinical trials of medicinal products and medical devices including the EU FP7-funded projects NEMO (www.nemo-europe.com), HIP (www.hip-trial.com), and IMPROvED (www.fp7-improved.eu/), and the Wellcome Trust funded ANSeR study (www. medscinet.net/anser). INFANT is a go-to centre for perinatal clinical trials and provides access to research active clinicians and state-of-art facilities. A supply of data from Europe’s second busiest maternity unit means we are well placed to offer a unique service to the diagnostics, devices and therapeutics industries.
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DIAGNOSTICS, DEVICES AND THERAPEUTICS TRIALS CENTRE
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Mobilising Perinatal Healthcare INFANT’s Connected Health strategy includes interfacing hardware electronics, innovative devices, and software with clinical applications tailored for use in providing monitoring solutions for pregnant women and newborn babies. The resultant technologies will address a broad spectrum of healthcare challenges, including early diagnosis and continuous monitoring during pregnancy and neonatal care. It comprises projects in the emerging field of mHealth - the use of mobile communications to provide health services. For the next generation, mHealth will revolutionise healthcare systems through smartphone apps, information communication, and the integration of mobile technologies with diagnostics and monitoring systems. In this way, perinatal mHealth will reduce costs and improve patient care and comfort through remote monitoring.
INFANT will bring convergent solutions to the perinatal healthcare arena, and will develop and validate platforms for the remote monitoring of early indicators of health status. This will facilitate personalised, woman-focused healthcare in the home and the community. This technology has the potential to have the greatest impact in research-poor areas of the world where facilities and clinicians are scarce. INFANT’s global health programme seeks to employ low-cost technology to circumvent the absence of sufficient health care infrastructures by utilising robust and extensively adopted cellular network services. Cloud computing and data-streaming projects, along with patient-at-home focused research programmes, means INFANT offers exciting opportunities to Irish technology companies.
A contributory factor in the explosion of mHealth is the increasing pressure on clinical services, which is driving a need for greater sharing of patient information, made possible through the emergence of electronic patient records.
A pregnant woman dies every minute CONNECTED HEALTH
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