Overview
One in eight babies born in the United Kingdom require neonatal care (about 80,000 every year) and 40% of all childhood deaths occur in the neonatal period. In survivors, neonatal conditions can impair lifelong health and development. Despite its importance much neonatal care is inadequately evidence-based because research is lacking. As a result care is variable and unequal.
It is neither financially nor technically feasible to tackle these manifold uncertainties using traditional approaches. Alternative methodologies, using routinely recorded data and electronic patient records, allow us to undertake research more rapidly and efficiently. My research aims to demonstrate the feasibility and value of novel approaches in addressing cardinal neonatal research questions.
Understanding how SARS-CoV-2 affects neonates
SARS-CoV-2 affects newborn babies in multiple ways. With the Policy Research Unit in Maternal and Neonatal Health and Care, based at the National Perinatal Epidemiology Unit I co-lead (with Professor Jenny Kurinczuk) national active surveillance of the neonatal complications of COVID-19.
Results from this work demonstrated that neonatal SARS-CoV-2 infection is uncommon and has good short-term outcomes. This informed national policy around shielding vulnerable groups of children and supports international guidance to avoid separation of mother and baby.
Ongoing work with Dr Ela Chakkarapani will follow-up these babies to determine whether SARS-CoV-2 infection has any long-term effects on development.
Using routinely recorded clinical data to improve neonatal care
Randomised controlled clinical trials are well recognised to be the optimal way to inform clinical care. However, for organisational or ethical reasons, some clinical uncertainties are not amenable to clinical trials. In such situations, carefully designed observational research using population-level data, such as that held in the National Neonatal Research Database, can inform optimal care.
We evaluated the impact of place of birth and early postnatal transfer following extremely preterm birth. This work demonstrates that birth in a non-tertiary hospital and transfer within 48 hours are both associated with poor outcomes (death and severe brain injury), when compared with birth in a tertiary setting. These and previous data have informed the organisation of neonatal services in the NHS and internationally.
We have used similar approach to evaluate optimal nutrition for term and near-term babies who receive therapeutic hypothermia for hypoxic-ischaemic encephalopathy, and optimal parenteral nutrition for very preterm babies.
Core outcomes for neonatal trials
Clinical trials are only as informative as the outcomes they measure. A large number of different outcomes have been evaluated in neonatal trials, and these are often not directly comparable. This limits evidence synthesis, meta-analysis and ultimately the evidence base that underpins neonatal care. Furthermore, the outcomes most important to parents, patients and other health professionals have not been defined.
We undertook a robust international consensus process that involved parents, patients, health professionals and researchers to define a core outcome set for neonatal trials. This work, Core Outcomes In Neonatology or COIN, identified 12 core outcomes for future research in neonatology. Routine use of these neonatal core outcomes will ensure that research addresses outcomes that are important to all stakeholders and can be readily synthesised.
Involving parents in neonatal data
The WHEAT (WithHolding Enteral feeds Around Transfusion) International trial is comparing two practices that are widely used in neonatal units across the UK and around the world to see if one reduces the risk of necrotising enterocolitis in preterm babies. Necrotising enterocolitis is a serious gut disease that affects about 1 in 20 very premature babies (approximately 500 each year).
The WHEAT International trial is currently recruiting in the United Kingdom and Canada and aims to be one the world's largest individually randomised neonatal trials, and one of the first trials powered to examine prevention of necrotising enterocolitis.
The WHEAT trial is a collaboration between Imperial College London and IWK Health Centre in Halifax, Canada, and with Dr Balpreet Singh and Prof Jon Dorling.
The WHEAT Trial - examining feeding around blood transfusion in preterm babies
The WHEAT (WithHolding Enteral feeds Around Transfusion) International trial is comparing two practices that are widely used in neonatal units across the UK and around the world to see if one reduces the risk of necrotising enterocolitis in preterm babies. Necrotising enterocolitis is a serious gut disease that affects about 1 in 20 very premature babies (approximately 500 each year).
The WHEAT International trial is currently recruiting in the United Kingdom and Canada and aims to be one the world's largest individually randomised neonatal trials, and one of the first trials powered to examine prevention of necrotising enterocolitis.
The WHEAT trial is a collaboration between Imperial College London and IWK Health Centre in Halifax, Canada, and with Dr Balpreet Singh and Prof Jon Dorling.
The neoGASTRIC Trial - examining routine measurement of gastric residual volumes in preterm babies
The neoGASTRIC trial is looking at whether not routinely recording gastric residual volumes before feeds in preterm babies is safe and beneficial in helping babies get to full milk feeds quicker. NeoGASTRIC is aiming to be the largest individually randomised trial in preterm babies ever undertaken and is being undertaken in the United Kingdom and Australia.
The neoGASTRIC trial is a collaboration with the National Perinatal Epidemiology Unit Clinical Trials Unit and Monash University in Australia, and with Dr Calum Roberts.
Collaborators
Professor Jenny Kurinczuk, Policy Research Unit in Maternal and Neonatal Health and Care, National Perinatal Epidemiology Unit, University of Oxford, Policy research in maternal and neonatal health, 2019 - 2023
Professor Lucy Chappell, Kings College London, Patient involvementResearch priority settingPregnancy hypertension, 2018
Prof William Tarnow-Mordi, National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Development of an international perinatal clinical trial network to undertake very large, simple clinical trials, 2017
Massachusetts Veterans Epidemiology Research and Information Center, United States Department of Veterans Affairs, Clinical trials embedded within existing data systems such as electronic health record systems, 2017
Clinical Associate Professor Jon DorlingClinical Associate Professor Shalini Ojha, University of Nottingham, Neonatal nutritionNational Neonatal Research Database, 2017 - 2019
Professor Brett D. Thombs, PhD, Faculty of Medicine, McGill University, CONSORT Extension for Trials Conducted in Existing Data Structures, Including Researcher-generated Cohorts, Registries,Electronic Health Records, and Administrative Databases, 2017
Associate Professor Ed Jusczak, National Perinatal Epidemiology Unit Clinical Trials Unit, University of Oxford, Clinical trials using electronic patient record data, 2017
Associate Professor Lyvonne Tume, University of the West of England, Paediatric and neonatal nutrition, 2017
Dr James Duffy, Nuffield Department of Primary Care Health Sciences, University of Oxford, Development of core outcome sets in women's health, 2015
Dr Kjell HeleniusProf Liisa Lehtonen, University of Turku, Perinatal health services, 2015
Miss Zoe ChiversMiss Mehali Patel, Bliss: the charity for babies born premature or sick, Parent involvement in neonatal research, 2013
Guest Lectures
Characteristics and outcomes of neonatal SARS-CoV-2 infection., 16th Paediatric Infectious Diseases: Infection and Vaccines, associação de saúde infantil de Coimbra, Lisbon, Portugal (online), 2021
Data for action in clinical settings., Plenary lecture; Perinatal Society of Sri Lanka, Annual Scientific Conference, Columbo, Sri Lanka (online), 2020
Neonatal SARS-CoV-2 infection: National UK data from active surveillance., PENTA Child Health Research Aperitivo, Online, 2020
Neonatal complications of COVID-19, World Health Organisation: Departments of Maternal, Newborn, Child and Adolescent Health, Virtual lecture, 2020
Introducing the CONsolidated Standards of Reporting Trials (CONSORT) statement for randomised controlled trials (RCTs) using cohorts and routinely collected health data., 5th International Clinical Trials Methodology Conference, Brighton, UK, 2019
Core outcome measures in neonatology., European Society for Paediatric and Neonatal Intensive Care 30th Annual Meeting, Salzburg, Austria, 2019
Development of reporting guidelines for randomized controlled trials using cohorts and routinely collected health data., Society for Clinical Trials 40th Annual Meeting,, New Orleans, USA, 2019
Using routinely recorded neonatal electronic patient record data to realise a neonatal learning healthcare system., University of Aberdeen, Aberdeen, 2018
Neonatology and the Obstetrician., East of England Advanced Labour Ward Practice Course, Cambridge Postgraduate Medical Centre, Cambridge University Hospitals, 2018
Making paediatric and neonatal clinical trials more efficient – trials that use existing data structures., Academic Paediatrics Association Annual Meeting, UCL, Great Ormond Street Hospital Institute of Child Health, 2018
Getting started: Research for all, Great Ormond Street Hospital, Institute of Child Health, 2018
Making a difference together: public involvement in health informatics research, Understanding Patient Data, Wellcome Trust, Wellcome Trust, London, 2017
Routinely recorded neonatal electronic patient record (EPR) data to realise a neonatal learning healthcare system: the UK experience, Harvard University, Beth Israel Deaconess Medical Center, 2017
Big Data and Point of Care Trials, British Association of Perinatal Medicine, BAPM Annual Conference and Scientific Meeting, 2017
New ethical perspectives in clinical trials, Europaediatrics, The 8th Europaediatrics Congress 2017, Bucharest, Romania., 2017
Efficient trials in neonatal medicine., Europaediatrics, The 8th Europaediatrics Congress 2017, Bucharest, Romania, 2017
Core data items to facilitate large, simple and efficient clinical trials., European Workshop on Neonatology, Westerberg, Germany, 2017
Using routinely recorded neonatal electronic patient record (EPR) data to realise a neonatal learning healthcare system, University of Pennsylvania, Children's Hospital of Philadelphia, 2017
Making a difference together: How can public involvement improve the relevance, acceptability, quality and impact of health informatics research?, University of Manchester, Farr Health eResearch Centre, 2017
All paediatricians are researchers, London School of Paediatrics, London School of Pediatrics’ Conference: “Empowering Unheard Voices”, 2017
Improving neonatal care through simple, efficient randomised point-of-care trials, University of Glasgow, Queen Elizabeth University Hospital campus, 2016
Big data for our smallest patients: a model for harnessing clinical data for research., UCL, Farr Institute of Health Informatics Research, 2016
Research Staff
Research Student Supervision
Altalib,S, The Association between Ethnicity, Deprivation, and Perinatal Brain Injuries in England
Chan,D, Management of Patent Ductus Arteriosus in babies admitted to UK neonatal units: a population-based study using the National Neonatal Research Database
Hage,L, Therapeutic creep in therapeutic hypothermia treatment for neonatal encephalopathy in the United Kingdom – a retrospective observational study using routinely recorded data
Helenius,K, Effects of Birth Outside Tertiary Hospitals and Early Postnatal Transfers in Extremely Preterm Infants: a Population Based Study
Prior,E, The Epic Study: The Ex-Preterm Phenotype in Childhood Study
Rees,P, Childhood outcomes after perinatal brain injury
Sakonidou,S, Improving the parent experience of neonatal care through better use of data
Singhal,G, • Timing of Stoma Closure in Neonates in England and Wales: 2014-2019
Taylor,E, Bronchopulmonary dysplasia in neonatal research: a systematic review
Webbe,J, Core outcomes in neonatology
Yao,S, Postnatal steroid use in preterm babies across England and Wales 2010-2019: a population study using the National Neonatal Research Database
jawad,S, Should Electronic Patient Record data be used for neonatal clinical trials?
van Hasselt,T, PREM-PIC - Potential Risk of childrEn born preMature requiring Paediatric Intensive Care: Examining risks of critical illness, and trends in paediatric intensive care utilisation for children born premature