Aim: Our aim is to improve the usefulness of an established UK resource, the National Neonatal Research Database (NNRD) for parents and for researchers so that they can view data and conduct studies to improve the care of preterm and sick newborn babies more quickly, efficiently and at lower cost than presently. About 1 in 7 (100,000 each year) newborn babies is admitted to a NHS neonatal unit. Neonatal problems and the care received, affect life-long health and well-being. Background: We established the NNRD, a unique, award-winning resource, in collaboration with parents, doctors, nurses, other healthcare professionals, and researchers to improve care, treatments and outcomes for preterm and sick babies admitted to NHS neonatal units. The NNRD contains comprehensive data, updated quarterly, from the electronic medical notes of all babies admitted to NHS neonatal units in England, Scotland and Wales. Imperial College London hosts the NNRD securely on a computer server. No data that can identify any individual baby are included. The data include details of diseases, daily treatments and outcomes. To-date the NNRD has information on about one million babies; around 25,000 new babies are added each quarter. Why this work is needed: We established the NNRD because a key challenge in newborn care is the need for up-to-date, timely and accurate data for research to improve, evaluate and develop new treatments. Data are required for all of the many types of studies needed, such as improving understanding of diseases, their causes and the care provided, and to develop new medicines. Different types of studies often need similar data (e.g. age, sex, weight, disease) but traditionally, researchers collect these again and again for each new purpose. This is expensive, wastes time and increases the risk of errors. Studies can fail because data availability or quality are poor. Data also need to be up-to-date otherwise information may be misleading. For example, information on health outcomes of very preterm babies that are widely used in the UK to counsel parents and guide clinical practice was derived from research conducted over 20 years ago and no longer reflects circumstances today. The NNRD provides a single source of up-to-date data for research and other purposes. This work is needed to improve the NNRD and make it more useful. Our objectives, and what we will do: We will automate processes to check accuracy and add new data into the NNRD that we currently perform manually. At present anyone who wants to use the NNRD must request our assistance, which inevitably incurs a delay. We will identify common types of information that researchers, parents and clinicians would find useful to obtain from the NNRD. This might be to determine the number of patients with particular conditions that are admitted to neonatal units. We will also obtain views on the way in which they would like to see the results (e.g. tables or graphs). This will help us develop web-based tools to enable parents and researchers to answer common questions themselves. We will make these tools available on our website. We will also develop ways to process NNRD data so that we can apply new techniques that can help identify patterns such as where particular types of disease occur and provide clues to their causes. Additionally, we will train young scientists in handling complex health data. Why this partnership is needed: We have formed a partnership because our objectives require skills across different organisations and disciplines. Our partnership brings clinical neonatologists, academic researchers and data scientists together with the national information technology lead for the health and care system in England (NHS Digital), expertise in data tools (Strategic Intelligence Alliance for Health; SIA), the national charity for preterm and sick newborn babies (Bliss) and the national institute for health data, Health Data Research (UK HDR-UK).

AIMS AND OBJECTIVES: We aim to reduce the cost, burden, and time to conduct randomised controlled trials (RCT) to improve the care of sick and preterm babies and develop medicines, diagnostics and devices that meet their needs. RCT are the most reliable and fair way to test treatments because every patient has an equal chance of receiving the best approach. Data collection is a major cost of RCT hence we will use data recorded as part of clinical care that is already available in a high-quality repository we established, the UK National Neonatal Research Database (NNRD). We will also use digital technologies and innovative study designs. The idea for NNRD-RCT is simple but the technical processes to flow data securely, develop and implement robust, transparent operational procedures, ensure trust in processes, and deliver solutions at scale, are complex, and our principal objectives. NEED: Neonatal care is an area of great national and global need. Newborn health sets trajectories for life; e.g. a baby born preterm, or over or underweight, is at up to 8 times greater risk of developing a chronic disease like diabetes or high blood pressure in adult life, that will decrease healthy life expectancy by as much as 15-20 years. Though improving their health has life-long benefits, newborn babies are disadvantaged in accessing biomedical innovations because of real or perceived difficulties in conducting RCT involving them. There has only ever been a single medicine specifically developed for a newborn condition, and over 90% of medicines used to treat babies have inadequate data on safety, dose, and efficacy because they have only been evaluated in older patients. This is dangerous because the way in which medicines work in babies is often very different from other age groups. Another difficulty is that reliably resolving healthcare uncertainties often requires the participation of large numbers of infants; e.g. to identify whether a treatment reduces severe retinopathy of prematurity, the major cause of childhood blindness, by 25%, would require a study involving about 14,000 infants which would be costly, difficult, and take a long time. Therefore many RCT, though needed, are never done or are too small or poor quality. The consequence is that there are many uncertainties in even routine aspects of care such as the best type of nutrition for preterm babies, and the best way to reduce the risk of infection. WHAT WE WILL DO: We will create standard operating processes to flow data from the NNRD to RCT master-files and electronic forms and digital tools e.g. for automated reminders and staff training. We will obtain stakeholder perspectives to build understanding and trust in NNRD-RCT and develop multi-media communications and transparent, well-governanced processes for commercial RCT. We will involve stakeholders in developing two exemplar NNRD-RCT (to resolve a long-standing, priority-ranked uncertainty in clinical care and to evaluate a neonatal medicine). We will also develop statistical and design solutions that maximise NNRD-RCT efficiency. Outputs will include resources to help clinical investigators, and guidance for industry researchers. WHY A PARTNERSHIP IS NEEDED: A partnership is needed to bring together expertise in scalable technical solutions that meet regulatory standards, develop NNRD-RCT design options, secure stakeholder involvement and engagement, and create impactful communications. Our partners are Bliss (national charity for sick and preterm babies), Health Data Research UK (national institute for health data science), Neonatal Society (clinical research society), Strategic Intelligence Alliance for Healthcare (SME supporting the NHS and industry), OpenClinica (provider of clinical trial cloud technologies) and UK Medicines and Healthcare products Regulatory Agency. The resources developed, know-how and knowledge, will be available to all clinical trials units and researchers around the world.