Clinical Studies

ENPR-EMA: Information on our Clinical Studies

Our Studies

INFANT conducts both small and large scale neonatal research studies, ranging from Ireland's first longitudinal Birth cohort (BASELINE) to single site proof-of-concept studies. All are conducted to ICH-GCP guidelines and are supported by INFANT platform staff and facilities.

The below details our ongoing and completed studies.

Baby feet in incubator

Ongoing Studies

CAPNO

The adaptation that all infants are required to make upon entering life outside of the womb is complex. Many physiological changes have to take place for the newborn to survive outside their mother’s womb once he or she has taken their first few breaths. Approximately 10% of all infants will require some help to make this adaptation. The CAPNO Trial is evaluating the role of quantitative versus qualitative carbon dioxide monitoring in very preterm infants in these first few minutes of life, with a view to improving neonatal transition and preventing hypocapnia/hypercapnia. When an infant requires resuscitation, the heart rate is a factor that helps in determining what treatments (or interventions) may be needed. Although the use of non-invasive electrocardiography (ECG) monitoring is a standard of care in the neonatal intensive care unit (NICU), it’s use is less well studied in the delivery room. Therefore, we hope to perform ECG monitoring in the delivery room on all infants included in this study.

CAPNO Website

 

CUPID

The CUPID study – Clamping the Umbilical cord in Premature Deliveries is a Randomised Controlled Pilot Trial.

This is a pilot study which is assessing three umbilical cord clamping strategies in preterm infants of less than 32 weeks gestation. The aim of the study is to compare maternal and neonatal outcomes following either immediate cord clamping, delayed cord clamping with ventilation initiated at the bedside and umbilical cord milking. Recruitment is ongoing in the delivery rooms of CUMH.

BABYLINK

Seizures or fits in newborn babies are classed as a medical emergency and require urgent treatment. However, they are impossible to detect without continuous brain monitoring using EEG. Specialist expertise is required for EEG interpretation and, all too often, no such expert is on-hand in neonatal intensive care units, which can result in important brain events being missed. Continuous monitoring of major vital signs is critical to aiding the clinical management of frequent complications associated with sick infants.

Over the last ten years, researchers and clinicians at the INFANT Centre have developed highly sophisticated algorithms to automatically analyse the neonatal EEGs. These algorithms can help to ensure that patients receive the care they need, even when expert neonatologists are not immediately available. The INFANT Centre has partnered with IBM to develop a solution based on IBM’s InfoSphere Streams computing platform, which allows the transmission of raw EEG data from the cot-side to the cloud. The platform takes the stream of data from sensors monitoring the baby, interprets that data using the algorithms created by INFANT engineers, and then sends alerts back to a Neonatal monitor. This surveillance service can be provided to multiple hospital rooms, or even multiple hospitals, in one location. Therefore the data moves and not the baby – crucial in saving time and minimising disturbance when dealing with infants in intensive care. To protect patient confidentiality, individual patient data is de-coupled from the monitoring alert data. Results can be securely viewed from any user authorised web-enabled terminal, PC, tablet or smartphone

BabySafe

The BabySafe project aims to develop an EEG/ECG electrode for monitoring the neurological wellbeing of the fetus during labour, and to develop a supporting algorithm to interpret the fetal EEG for non-expert users.

The product being developed for BABYSAFE  is a multi-modality (EEG, ECG) sensor array (Fetal Scalp Electrode : FSE) which can be attached to the scalp of an infant during delivery, which can then be connected to a recording system to record fetal heart rate, maternal heart rate and fetal EEG activity.

A small cohort of expectant mothers have been recruited to the study. The pilot has focussed on capturing ECG from pregnant women using electrodes placed on the abdomen. Initially ultrasound was used to locate the fetal heart, and direct electrode placement on the abdomen. Currently a ‘kite electrode placement’ is used to capture the Fetal ECG and ultra sound used to monitor movement of the fetus. This preliminary study is providing the necessary data to allow INFANT engineers to separate and distinguish mothers’ heartbeat from the fetal heartbeat.

 

BASELINE

BASELINE is the first Irish birth cohort study. There are a number of birth cohort studies worldwide, but few, if any of them will have such detailed information about the babies from before they are even born, way back to the first weeks of pregnancy.

The BASELINE study is a collaborative study between the Departments of Paediatrics and Child Health, Obstetrics and Gynaecology and Food and Nutritional Science, University College Cork, and the Department of Dermatology, Trinity College, Dublin. Recruitment of mothers took place in Cork University Maternity Hospital and follow up of the BASELINE children will take place in the HRB-CRF- Cork Children’s Discovery Centre in Cork University Hospital. Children were seen at 2, 6, 12 and 24 months and the 5 year follow up is currently taking place. Initially focusing on three main research questions: the effects of poor growth in the womb, the incidence and prevalence of food allergy and eczema in early childhood and the incidence and effects of maternal and infant vitamin D status on the growth and health of Irish children.

BASELINE is also storing maternal blood samples taken during pregnancy and samples from the babies’ umbilical cord at birth. This will allow us to look back later to see if any elements in the umbilical cord, or mother’s blood could have been used to predict disease in these children.

 

BiHIve

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. The BiHIvE project 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. BiHiVe is closed to recruitment but currently following up all of the Infants enrolled.

Website: BiHIvE

 

COMBINE

The main goal of the COMBINE -The COrk Nutrition and MicroBiome Maternal-InfaNt Cohort Study is to improve our understanding of diet and gut microbiome composition for healthy growth and neurological development in early childhood.

COMBINE represents a unique collaboration between INFANT and APC and our industry partner Mead Johnson Nutrition. COMBINE is a prospective longitudinal mother-infant birth cohort study with a parallel dietary intervention study of an investigative formula. Recruitment for IMPROvED, an EU funded pregnancy cohort among primiparous women, is on-going at CUMH and COMBINE is recruiting infants born to these mothers.

COMBINE is:

– Conducting a detailed, quantitative prospective analysis of infant feeding over the first 24 months, including brand-level data on formula and supplemental products. These data will enable us to determine the effects of diet on early growth and development, body composition, and nutritional status over the first two years of life, with validated early obesity and neurological health outcomes.

– Defining the influence of mode of delivery, early life events (e.g. infection and antibiotic use) and early feeding practices on the composition of the gut microbiota of infants.

– Establishing how the gut microbiome can enhance nutritional status in infants with downstream benefits on body composition and neurological development.

– Establishing a state-of-the-art biobanks for maternal and infant samples, including blood, DNA, RNA, stool, saliva and human milk supported by a bespoke online, quality assured, secure and detailed phenotype meta-database to develop biomarkers (and/or algorithms) for early detection and provide a foundation for investigating future hypotheses in the cohort as it grows.

Facebook Combine Cohort Study 

 

NEOVIEW

The NeoView project aims to improve patient outcome, reduce parental stress, and increase procedural success rates in the neonatal intensive care environment. This will be achieved by introducing innovative technology, which enables enhanced monitoring and enhanced staff and parental education, into said environment.

NEOVIEW will provide families with virtual visitation to their child; enabling clinicians to improve the level of care when they are not on the unit and; enhancing patient outcomes through improved care regime and enhanced education for training staff. As a result, the journey of infants, and their parents, through the NICU will be enhanced which aligns with the centre’s objective to deliver beneficial interventions that will fundamentally change perinatal care

In addition, there will be parental educational content that can be accessed at the point of care and remotely. The impact of the technology on parental wellness and stress will be assessed. By enhancing the experience of parents and families in such difficult circumstances, parental-infant bonding can be improved, ultimately leading to shorter hospital stays. In addition, by improving health outcomes for new born babies through a reduction in procedural related errors, and through positively addressing health issues such as familial stress, the NeoView project will have a number of impacts upon healthcare economics leading to savings for the health system.

 

NESTED

This industry-partnered project will develop, test and train a seizure detection algorithm for premature babies in the Neonatal Intensive Care Unit. We have access to a unique data set for this purpose, and the steps involved will include feature selection, data classification and data validation. The algorithm will be developed in a regulatory compliant way so that it is ready for licence within 3 years. The project aims are to:

-Develop a robust, reliable, automated seizure detection system for the detection of seizures in preterm neonates and facilitate prompt treatment;

-Validate this algorithm on a large multi-centre dataset;

-Prepare the algorithm in a regulatory compliant manner such that this algorithm is ready for licence at the end of the project.

 

NEUROPROBE

Sustained periods of low Blood Pressure (BP) in preterm babies can lead to brain injury. At the same time the excessive treatment of low blood pressure has been associated with increased risk of poor neurodevelopmental outcomes. In fact, many babies do not show any physical sign of distress and may not need any treatment. To the end, the ‘permissive hypotension’ is appropriate where the babies with only a clear sign of brain dysfunction are treated.

In the NICU, it is difficult to continuously monitor neurological function which is done by means of EEG and brain oxygenation (NIRS). We know that these signals may be altered by significant periods of low BP but despite the importance of this information for clinical management the clinical team caring for the preterm baby find it difficult or impossible to interpret these signals at the cot-side. NEUROPROBE will develop an innovative method of continuously analysing changes in preterm EEG, NIRS and blood pressure data and present this information in real time as a brain health index. Periods of low BP that have significant impact on brain oxygenation and activity can thus be rapidly identified and appropriate therapies administered. NEUROPROBE will develop an automated multimodal EEG, BP and cerebral oxygenation monitoring system, to be used for constant surveillance in the preterm neonate, based on advanced signal processing and machine learning-based decision making.

 

PiNPoINT

PiNPoINT (Personalised Nutrition for the Preterm Infant) is a large-scale project aiming to implement a novel nutritional management strategy in preterm very low birth weight (VLBW) infants using real-time nutritional data collection and monitoring. PiNPoINT follows from the results of the BabyGrow longitudinal preterm nutrition study that quantified nutrition and growth in a small cohort of preterm infants. The project aims to address the lack of knowledge around nutritional requirement in VLBW infants to optimize growth and development of bone, body composition and brain tissue for improved functional outcomes and promotion of long-term health and quality of life. This is the largest project of its kind in Ireland.

 

SafeBooSC

SafeBooSC-II Safeguarding the brain of our smallest children – a phase II feasibility randomised clinical trial on near-infrared spectroscopy monitoring combined with a treatment guideline in premature infant. INFANT is a participant in the SafebooSC II trial, which was funded by the Danish Strategic Council to assess the role of cerebral oxygenation monitoring in extremely preterm infants in the first three days of life. The short term results of this study have recently been published, showing that cerebral oxygenation monitoring, with a treatment guideline, resulted in a reduction in the amount of cerebral hypoxia in the first three days of life. Long-term neurodevelopmental outcome is ongoing and the next stage of the project is to conduct a significantly larger study enrolling 1600 infants across Europe

Website: SafeBooSC

 

SmarTi

The SmarTi – Stressed Microbial Transfer to the Infant project aims to determine the impact of Maternal Prenatal Stress (MPNS) and Maternal Irritable Bowel Syndrome (MIBS) on the intestinal microbiota during pregnancy. The project will also determine if this ‘stressed microbiota’ is transmitted to the infant at birth. We are assessing the consequence of these changes as the infant microbiome is seeded and developed.

Mum holding baby in maternity ward

Completed Studies

CO2 IN THE DELIVERY ROOM

Respiratory Adaptation following elective Caesarean section at term to look at  Rates, Tidal Volumes and End Tidal CO2 in the First minutes after birth In order to assess respiratory rate, tidal volumes and end tidal carbon dioxide (ETCO2) patterns in term infants during the first minutes of life following caesarean delivery and determine whether these are associated with transient tachypnea of the newborn. Between May and October 2015, one hundred infants were recruited to this study and data analysis is ongoing.

DELIVERY SUITE NIRS MONITORING

The objective of the Delivery Suite NIRS Monitoring study is to compare the NIRS cerebral oxygenation monitoring in preterm infants of less than 32 weeks who receive higher versus low concentrations of oxygen for neonatal transition at birth.  Over a 15 month period 45 infants were recruited to the study up to the end of June 2015. Data collection and data analysis has been ongoing since then.

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