Clinical trials

This study will examine how eating behaviour changes during the first 18 months of treatment with obesity medications in patients attending the St Vincent's Healthcare Group obesity service. Obesity is increasingly understood as a chronic, relapsing, multifactorial disease that requires long-term management rather than short-term advice alone. Newer anti-obesity medications, particularly glucagon-like peptide-1 receptor agonists and related therapies, have improved weight-loss outcomes and altered the experience of hunger, fullness, food reward, and meal size for many patients. However, while weight reduction is well described in the literature, less is known about how patients themselves experience eating behaviour over time as treatment progresses from initiation to active weight loss and then towards weight maintenance. This study is designed to address that gap by exploring the lived experience of appetite and food-related behaviour across clinically meaningful stages of treatment. The study will use a longitudinal mixed-methods design. Thirty participants aged 16 to 80 years with a body mass index above 27 kg/m2 who are commencing weight-loss medication as part of routine care will be recruited. The sample size includes an allowance for a modest dropout rate over the study period. Participants will be followed at four time points: baseline, approximately 3 months after treatment initiation, around 12 months, and at 18 months, with a visit window of plus or minus 13 days. These time points were selected to reflect distinct phases of treatment. Baseline will capture pre-treatment or very early-treatment experience. Three months is expected to reflect a period of early therapeutic response, when medication effects on appetite may be most noticeable. Twelve months is likely to represent a later phase, when weight loss may be slowing and some patients may be approaching their lowest weight. Eighteen months is intended to capture maintenance or stabilisation, when behavioural changes may differ from those seen earlier in treatment. Data collection will include both questionnaires and semi-structured telephone interviews. The questionnaire component will measure key aspects of eating behaviour, including hunger, fullness, food thoughts, portion size, and palatability. Repeated administration at each study time point will allow changes in these behaviours to be tracked over time. The interview component will provide a richer understanding of how participants describe and interpret their experiences. All interviews will be conducted by one co-investigator using the same core interview guide to ensure consistency. Open-ended questions will allow participants to describe changes in appetite, eating patterns, cravings, meal satisfaction, food preferences, and daily routines in their own words, while additional probing may be used to clarify how these experiences evolve through treatment. Interviews are expected to last 15 to 45 minutes, will be audio-recorded with verbal confirmation, and transcribed for analysis. The central research question is how hunger, fullness, food thoughts, portion size, and food palatability change over time during treatment with obesity medications. The hypothesis is that appetitive and consummatory behaviours will decrease from baseline to an early low point, particularly around 3 months, and may then gradually rise again as treatment continues, before stabilising during a later maintenance phase. This pattern would reflect the possibility that the strongest appetite-suppressing effects occur early, followed by behavioural and physiological adaptation over time. At the same time, the study recognises that patients may not all follow the same course, and individual variation will be an important part of the analysis. Quantitative data will be used to describe behavioural trends across time points, while qualitative data will be analysed thematically to identify recurring experiences, challenges, and adaptations. Integrating these two forms of data will strengthen the study by linking measurable change with patient perspective. The study is expected to provide clinically useful insight into how anti-obesity medications influence the lived experience of eating, and how this may change between the active weight-loss phase and maintenance. By focusing on patient-reported hunger, satiety, food preoccupation, portion size, and palatability, the research may help clinicians better understand when patients need additional support, how expectations can be managed, and what aspects of treatment are most important for long-term success. The findings may also contribute to more personalised obesity care by highlighting the behavioural dimensions of treatment that are not captured by weight change alone.

Blood clots in the legs or lungs (called venous thromboembolism or VTE) are one of the most serious complications after weight loss surgery. Most blood clots occur after patients go home from hospital, within the first 30 days after surgery. To prevent blood clots, all patients having weight loss surgery receive a daily blood-thinning injection for 21 days after their operation. Two blood-thinning injections are currently used at St Vincent's University Hospital for this purpose: enoxaparin (Clexane®) and tinzaparin (Innohep®). Both belong to a group of medicines called low molecular weight heparins (LMWHs). Patients with obesity process these medicines differently to the general population, and previous studies from our hospital have shown that fewer than 53% of patients achieve adequate blood-thinning levels with either injection when measured by a blood test called an anti-Xa level. Patients will be randomly assigned (like a coin toss) to receive either tinzaparin or enoxaparin for 21 days after their surgery. Both injections are already in routine use at this hospital. A single extra blood sample will be taken on the second day after surgery to measure the anti-Xa level, which tells us whether the injection is providing adequate protection against blood clots. This blood sample will be taken at the same time as routine post-operative blood tests so that no additional blood draws are required. The study will also look at rates of blood clots and bleeding events within 30 days of surgery, and will ask patients to complete a short questionnaire at their six-week follow-up appointment about their experience with the injection.

When babies can't breathe effectively, we can use a facemask to give them breaths and oxygen. There are various types of facemasks that can be used, including round and anatomical (triangular) masks, depending on the preference of the hospital, but it is unclear if one is better for the baby. Both types of facemasks are recommended in international guidelines, without any advice whether one is better than the other. Previous studies published by our research group demonstrated that a variety of different masks are used around the hospitals in Ireland. If a lot of air is leaking around the mask, it means that the baby is not getting the full breathing support that we are trying to give. We currently do not have enough evidence to say which type of mask is better to reduce the risk of this potential leaking of air. Recent studies have suggested that holding a mask with two hands (instead of one) is better in round facemasks. The combination of an anatomical mask and a two-handed hold has not yet been studied in babies. In this study, we will compare two different facemasks (round and anatomical) when holding the mask on a baby's face with two hands to help them breathe. We will randomly allocate each baby to either a round mask or an anatomical (triangular) mask and we will measure how much air leaks out around the mask during each breath. We will do this in babies who are in the neonatal unit.

The aim of this study is to determine whether encapsulation of probiotic bacteria using natural plant protein can enhance bacterial colonisation. Lactobacillus rhamnosus is an ideal strain for the intervention, as it has been shown to affect overall gut health, gut-brain axis, and brain function. Twenty-five participants aged 25 to 65 years will be recruited and assessed on four occasions to compare the blood and faecal effects of a 28-day ingestion of a yoghurt beverage with and without the probiotic strain of interest. The study window will be 70+/13 days. The current study will provide important information on the physiological function of probiotics in the small bowel. Understanding the underlying physiological effects of targeted probiotic delivery to the intestine and the impact on the microbiome is important for health outcomes.

Many newborn babies have difficulty breathing. When babies need a lot of help, a doctor will intubate them - i.e. put a tube into their windpipe (trachea) - so that they can be given support with a breathing machine. Intubation is a difficult procedure, during which many babies have falls in their blood oxygen levels and heart rate. When doctors intubate babies, they use a device called a laryngoscope to identify the entrance to the windpipe. A standard laryngoscope has a light at its tip. When doctors use this device, they insert it into the baby's mouth and then look directly into the mouth to find the entrance (direct laryngoscopy). Less than half of first attempts to insert a tube are successful using this device. More recently, video laryngoscopes have been developed. These devices also have a camera at the tip and display a magnified view of the entrance to the windpipe on a screen. A study at one hospital showed that the doctors there inserted the tube at the first attempt more often when they used a video laryngoscope instead of a standard laryngoscope. This study was not large enough to see whether fewer babies had low oxygen levels or heart rate during the procedure. The goal of this clinical trial is to see whether more newborn babies are intubated at the first attempt without falls in their blood oxygen levels or heart rate when the doctors use video laryngoscopy compared to direct laryngoscopy. Hospitals where doctors routinely intubate babies by looking directly into the mouth will take part in the NEU-VODE study. From the start of the study, the doctors at each hospital will continue with their usual approach to intubation and collect information about intubation attempts. As the study progresses, the doctors at each participating hospital will switch one--by-one to routinely attempting intubation with a video laryngoscope. The date on which they switch will be determined by chance. By the end of the study, each hospital will have had a study period where babies were routinely intubated using direct laryngoscopy and video laryngoscopy. At the end of the study, the information collected from all the babies intubated during the study will be compared to see if more babies were successfully intubated at the first attempt without falls in their blood oxygen levels or heart rate in the video laryngoscopy group.

The prevalence of obesity is rising worldwide, both in low- and high-income countries, including people with HIV (PWH). Semaglutide's efficacy in achieving weight loss in obese PWH is still unexplored. The aim of this study is to assess the efficacy and safety of semaglutide in achieving greater weight loss compared to diet and excercise alone in obese PWH and to explore the effect of semaglutide on the immune function, markers of immune activation, viral reservoir, markers of glucose and lipid metabolism and gut microbiome.

This study will determine whether encapsulation of probiotic bacteria using natural plant protein can enhance bacterial colonisation. Lactobacillus rhamnosus is an ideal strain for the intervention, as it has been shown to affect overall gut health, gut-brain axis, and brain function. Participants aged 25 to 65 years will be recruited and assessed on four occasions to compare the effects of the blood chemicals and bacterial composition in faeces of a 28-day ingestion of a yoghurt beverage with and without the probiotic strain of interest. The study window will be 70+/13 days. This study will provide important information regarding the physiological function of probiotics in the small intestine. Understanding the underlying physiological effects of targeted probiotic delivery to the intestine and the impact on the microbiome is important for health outcomes.

Introduction: Chronic pain significantly impacts quality of life and requires comprehensive management strategies. Traditional pain education programs are beneficial but often require significant and prolonged patient engagement. Virtual reality (VR) offers a novel approach by creating immersive environments that may enhance the effectiveness of pain education. This protocol outlines a feasibility study to investigate the use of a Virtual Reality (VR) pain education program for people living with chronic pain (PwCP). Aim of the investigation: To evaluate the feasibility and acceptability of delivering a VR pain education program for PwCP. The secondary aim will explore the pre-to-post-test changes in clinical outcomes as proof of concept for a future larger scale investigation. Methods: We will use Reality Health™ as the VR tool to deliver pain science education. The study will be conducted as a single-arm feasibility study using a pretest:posttest design. Fifty PwCP will engage in the six-week Reality Health™ programme. This education programme focuses on the neurophysiology of pain, pain modulation techniques, cognitive-behavioural strategies and guided virtual exercises. Results: Primary outcome measures will include the feasibility, acceptability and safety of Reality Health™ including recruitment, retention, intervention adherence and attrition rates. Secondary outcomes will explore the pre-to-post-test changes in outcome measures relating to pain intensity, pain interference, pain self-efficacy, pain self catastrophizing, quality of life and depression as proof of concept for a future larger scale investigation. Conclusions: Results will establish the feasibility, acceptability and safety of using Reality Health™ in the treatment of chronic pain, informing a future randomised control trial. Ethical approval: Ethics has been granted from University College Dublin's Human Research Ethics Board (HREC-LS-25-868587). Acknowledgements: This work is funded through the Interreg north-west Europe project 'Scale-Up Rehab,'approved and funded by the European Commission \[NWE0100082\]. Disclosures: None. Keywords: Virtual Reality, Chronic Pain, Pain Education, Feasibility Study, Protocol

The aim of this study is to examine the impact of a concurrent training exercise intervention on menopausal symptoms and key physical and mental health outcomes. The proposed study is powered based on a primary outcome of examining the change in menopausal symptoms using the MenQoL questionnaire. Participants (n=70) will be randomised to an intervention or control group. The intervention group will participate in a 12 week online (via zoom) concurrent training programme, consisting of three forty-five minute sessions (on non-consecutive days) per week that align with WHO exercise recommendations for adults and the control group will maintain their regular activity. The exercise classes will be delivered by qualified Sport \& Exercise Scientists and will consist of a combination of bodyweight and resistance band exercises. Each class will consist of a 5 minute warm up, 15 minutes of aerobic exercise, 20 minutes of resistance training, and a 5 minute cool-down. Both groups will engage in pre and post testing through questionnaires (GAD-7, Patient Health Questionnaire-9 (PHQ-9), Menopause-Specific Quality of Life Questionnaire (MENQOL), Body Appreciation (BAS-2)), Pittsburgh Sleep Quality Index Sleep, International physical activity questionnaire (IPAQ), Body image questionnaire (BAS-2) and physical tests (Bod pod, grip-strength, 3-RM leg press, 3-RM cable pull, counter-movement jump and Astrand Rhyming submaximal aerobic test).

This study is evaluating whether a supervised resistance training (strength training) programme is feasible to perform in a first-episode psychosis service. It is also evaluating if resistance training can prevent harmful weight gain and improve physical health in people who have recently been diagnosed with First-Episode Psychosis and are starting antipsychotic medication. Antipsychotic medications are essential for treating psychosis, but they frequently cause rapid weight gain and metabolic side effects (such as changes in blood sugar and cholesterol) within the first few months of treatment. Resistance training is a form of exercise that builds muscle and improves how the body uses energy. An excess of calories, which would otherwise lead to accumulation of fat (adipose tissue), can help build strength and increase muscle size when paired with resistance training. Participants in this study will be randomly assigned to one of two groups: Intervention Group: Participants will receive their standard medical care plus a 12-week resistance training programme. This involves attending two 60-minute exercise sessions per week, supervised by a qualified instructor. The sessions will include exercises using resistance bands, machine weights, and free weights tailored to the individual's ability. Control Group: Participants will receive standard medical care only for the first 12 weeks. The study uses a "crossover" design, which means that after the initial 12 weeks, the Control Group will be offered the same 12-week resistance training programme. The main goals of this study are to determine if it is feasible to run this type of exercise programme for this group of patients and to measure the effects of the training on body fat levels, muscle strength, and overall physical and mental health

The aim of this study is to test the efficacy, feasibility, and acceptability of the UCD PLAN'EAT Living Lab in promoting sustainable and healthy dietary behaviours among university students. This study will compare within participant changes in diet-related pre-specified outcomes (detailed below) at Living Lab baseline and endpoint and examine differences across participant engagement levels (e.g., low engagement versus high engagement) in Living Lab studies and events/ activities.

This prospective, observational cohort study will evaluate the associations between wearable-derived biometrics and cardiovascular health, quantified by the American Heart Association's Life's Essential 8 framework, as well as related cardiovascular risk factors. The study aims to determine whether wearable biometrics can support the assessment of cardiovascular health and cardiovascular disease risk, both when used in isolation and in combination with point-of-care assessments.

The goal of this clinical trial is to investigate if blood glucose responses are similar between and within individuals in response to standardized exercise in adults with and without Type 1 diabetes. The main questions it aims to answer are: What is the reproducibility of acute glycaemic responses to exercise within and between subjects in adults living with Type 1 Diabetes and in healthy adults? What is the agreement between glucose levels obtained by continuous glucose monitor (CGM) and blood glucose monitor? Participants will cycle on a cycle ergometer or rest after consuming a standardized breakfast, while glucose levels are monitored by CGM and capillary blood sampling.

Gestational diabetes mellitus (GDM) affects approximately 1 in 7 pregnancies globally and is associated with significant short and long-term health consequences for both mothers and infants. While lifestyle interventions during pregnancy can effectively reduce GDM risk and its complications, there is limited guidance on how to translate this evidence into routine antenatal and postpartum care. This project looks to address this gap by exploring the effectiveness of the B2B\&Me+ programme within regular maternity services across four European countries and how best to implement it. Women identified as being at higher risk of developing GDM using a GDM screening tool will receive access to the smartphone application that connects them with their health coach, who will provide personalised support about healthy eating, physical activity, mental wellbeing, and infant care from early pregnancy until 9 months after birth. The participants will be randomised initially to a specific referral pathway for the intervention.

This study explores the feasibility of ContextWell, a well-being education programme that combines an online webinar with an AI-powered behavioural nudging system. The programme aims to support university students, particularly those in healthcare disciplines, in enhancing well-being and adopting healthier lifestyle habits. The primary objective is to determine whether the programme can be feasibly delivered within university settings. A secondary objective is to assess its potential to improve student well-being and encourage behavioural changes aligned with lifestyle medicine principles. The intervention builds on the understanding that healthcare professionals' lifestyle habits and well-being have a direct impact on patient care. Focusing on healthcare students helps advance the integration of lifestyle medicine within health education and clinical practice. This single-group feasibility study delivers the full intervention to all participants. Students participate in an online well-being webinar and receive AI-generated behavioural prompts designed to promote self-awareness and healthier daily choices. Key evaluation measures will indicated the feasibility of the programme among young adults in academic environments. Participant feedback and initial outcomes will support future development and inform larger-scale research.

This will be a prospective, multi-centre study at a National Tertiary Referral Centre for spinal trauma and spinal cord injuries, serving a catchment area of 5 million people. This study will follow patients undergoing anterior lumbar interbody fusion (ALIF) procedure. This trial seeks to evaluate the performance of this CE-marked device, and to assess outcomes in frail and non-frail patient cohorts. The CONDUIT™ ALIF Cage System are intervertebral body fusion devices intended for use for anterior lumbar interbody fusion in skeletally mature patients. The devices are 3D printed cellular titanium implants that feature 80% porous macro-, micro- and nanostructures, are designed to mimic cortical and cancellous bone, and facilitate fusion. This pilot study hypothesizes that the use of CONDUIT ALIF Cage system to treat lumbar degenerative disc disease will achieve results comparable to historical cases using SYNFIX Systems.

The aim of this study is to conduct a mixed methods process evaluation of the META trial. Semi-structured interviews, focus groups, and brief questionnaires will be conducted with a purposive sample of participants (patients and healthcare providers) who were involved in the trial to explore the feasibility, acceptability and perceived effectiveness of the trial intervention.

This research focuses on one of the most common problems in newborn medicine: breathing difficulties. Breathing problems are the most common reason for admission to our neonatal unit at the National Maternity Hospital. When a baby has serious breathing difficulty, inserting a breathing tube to place them on a ventilator can be lifesaving. A breathing tube must be placed through the vocal cords into the windpipe (trachea). A device called a laryngoscope is placed in a patients mouth to allow the doctor to see the vocal cords and insert the tube correctly. The skill of placing this breathing tube (intubation) is important for doctors and specialists to learn so that they can confidently perform it in an emergency. In the past, doctors had more opportunities during their training to learn and practice this with supervision from seniors. In recent years, babies, thankfully, need to be intubated less frequently and doctors working hours are better regulated. As a result, junior doctors have less chances to perform this skill. There is a need to improve how we teach the procedure of intubating babies to doctors in training to meet the needs of trainees today. The investigators want to perform a study to help teach doctors in training how to perform intubation of a newborn using a video laryngoscope. The team are looking to assess if showing a short educational video to the doctor and team just before performing an intubation using a video laryngoscope will reduce the time the procedure takes. This is called a "Just-in-Time" video. The investigators aim to demonstrate a benefit by performing a randomised control trial. This means that when a baby requires intubation as decided by their treating doctors, the team will be randomly allocated to view a "Just-in-Time" video before performing the intubation or not. The investigators will then compare the two groups to see if there is a difference in the total time the procedure takes.

Many premature babies have breathing difficulty after birth and receive help with a breathing machine (nasal continuous positive airway pressure, NCPAP). Some of the babies whose breathing gets worse despite NCPAP are treated with surfactant, a medication that is given directly into their windpipe (trachea). Some of the babies who are given surfactant get it through a ventilation tube (endotracheal tube, ETT), while others get it through a thin catheter that is too small for ventilation. When doctors insert a tube or a thin catheter into the windpipe of a baby, they use an instrument called a laryngoscope, which has a light at its tip, to identify the entrance. Most often doctors look directly into the baby's mouth with a standard laryngoscope to identify the entrance to the windpipe. However, newer video laryngoscopes have a camera along with the light at their tip, which displays a picture of the entrance to the windpipe on a screen. In a study performed at one hospital, doctors inserted an ETT first time more often when they used a video laryngoscope. The investigators are doing a study at many hospitals where doctors usually use a standard laryngoscope to insert tubes and thin catheters into a baby's trachea by looking directly into the mouth. Each hospital will switch one-by-one to using a video laryngoscope when inserting a tube. The investigators will compare the information we collect to see if more babies who have a tube inserted first time without falls in their oxygen levels or heart rate with a video laryngoscope. The investigators will also collect information on babies who have a thin catheter inserted to compare whether doctors use fewer attempts when they use a video laryngoscope.

This will be a prospective, multi-centre study at a National Tertiary Referral Centre for spinal trauma and spinal cord injuries, serving a catchment area of 5 million people. Consecutive patients undergoing posterior-only surgery or combined anterior and posterior surgery for degenerative cervical pathology, traumatic spinal fractures or dislocations, failed previous fusions or treatment for tumour involving the cervical/thoracic spine will be enrolled. This is a post-market trial, with a CE-marked medical device called the SYMPHONY OCT System which is currently in use in both centres. The SYMPHONY™ OCT System is a portfolio of internal fixation tools including screw, rods and hooks used as an adjunct to fusion for posterior stabilisation of the upper spine in skeletally mature patients. This pilot study hypothesizes that the use of SYMPHONY™ OCT System to treat upper spine instabilities will achieve results comparable to historical cases using the Mountaineer performed until 2021.

This trial will evaluate the feasibility of a pilot educational intervention for GPs that aims to enhance care and care outcomes among patients with long COVID at six general practices in the Ireland East region. Our first objective is to conduct focus groups with key stakeholders (GPs, other health professionals, patients, families/carers) that will inform the contents of an education intervention. The second objective will be to implement this educational intervention, and the third objective will be to determine whether the intervention is feasible. Study outcomes will include: * Qualitative findings from co-design focus groups and post-intervention semi-structured interviews with GPs. * Practice and patient study recruitment and retention data. * GP / Practice characteristics: age \& gender, practice location, general and COVID-19 patient population figures. * Patient characteristics: Patient age, gender, COVID-19 vaccination status, and medical history details. * Patient scores on a self-report measure assessing the symptoms, symptom severity, functional impact, and overall health (COVID-19 Yorkshire Rehabilitation Scale (C-19-YRS)).

The goal of this clinical trial is to learn whether giving surfactant through a thin endotracheal catheter to extremely premature babies shortly after birth reduces the number of them who are ventilated in the first 3 days of life. The main question it aims to answer is: Do fewer babies who receive prophylactic thin catheter surfactant under video laryngoscopy shortly after birth go on to be ventilated within 72 hours of birth? Extremely premature babies who are receiving breathing support through a face mask will either: * Receive surfactant through a thin catheter that is inserted into their windpipe (trachea) under video laryngoscopy at or after 5 minutes of life, have the catheter removed immediately, and return to face mask breathing support; or * Continue on face mask breathing support. All babies will be closely watched to see whether they are ventilated for breathing support in the first 72 hours of life.

Stroke is the third most common cause of death worldwide and the leading cause of disability. High blood pressure is an important risk factor for stroke. Lowering a person's blood pressure reduces the risk of future stroke or heart attack, and current guidelines recommend treatment to a target of \<130mmHg for secondary prevention. Home blood pressure measurement and telemonitoring are acceptable to patients, but there is uncertainty over the use of out of office blood pressure measurements in stroke patients in guidelines. This is a study designed to establish the feasibility of a larger clinical trial, comparing home blood pressure monitoring, telemonitoring and medication titration with standard care. The study hypothesis is that home BP measurement and telemonitoring with medication titration may lead to improved BP control compared to standard of care clinical practice.

Tobacco smoking in pregnancy is now widely accepted as having adverse health outcomes for both the mother and fetus. Tobacco smoking in pregnancy is associated with increased incidence of miscarriage, stillbirth and preterm birth as well as low birthweight, respiratory infections, wheeze and asthma in childhood. E-cigarettes are a popular method for trying to quit smoking in Ireland and there has been an explosion in the use of e-cigarettes over the past ten years. However, there is currently insufficient evidence on their long-term safety and effectiveness as a smoking cessation tool. E-cigarettes contain varying combinations of compounds and flavours which are used differently in different e-cigarette types, with unknown long-term effects. Research has shown that pregnant women perceive e-cigarettes to be a healthier option when compared with tobacco smoking. But, there is very little known about the long-term health impact of exposure of unborn babies to e-cigarettes during pregnancy. The ECHO study will determine what the long-term health outcomes are in children born to mothers who use e-cigarettes during pregnancy. Specifically, we will focus on birth, nutritional, brain development and respiratory outcomes in children. To answer this research question, the ECHO study will recruit infants born to women who use e-cigarettes during pregnancy across three maternity hospitals and follow them up over 2 years. We will invite women at their booking visit to take part in this research study. We plan to also recruit a similar number of both non-smoking and tobacco smoking pregnant women for comparison. We will record a detailed record of e-cigarette and tobacco use by women during pregnancy as well as checking smoking using special monitoring tools. After the baby is born, we will perform growth measurements, neurocognitive assessments and a respiratory questionnaire at 6 months, one year and two years of age.

Platelet transfusions can help clotting but may also have risks. Currently when babies get platelet transfusions they get as much as three times (per kilogram of body weight) as much as adults do. The goal of this clinical trial is to to find out which volume of platelets should be transfused to premature babies with low platelets and no bleeding. The main question it aims to answer is if a smaller volume for platelet transfusion can help prevent death and severe bleeding and also have fewer side effects for the baby. Participants will be placed at random into one of two groups: In Group 1, babies will get a platelet transfusion based on the volume of 5mls/kg weight, in Group 2, babies will get a platelet transfusion based on the volume of 15mls/kg weight. Babies will remain in their allocated group during their stay on the neonatal unit so that they always receive the allocated volume unless a clinician decides otherwise.