Imperial College London

Dr Chris Gale

Faculty of MedicineSchool of Public Health

Professor of Neonatal Medicine



+44 (0)20 3315 3519christopher.gale Website




Academic Neonatal Medicine, H4.4,Chelsea and Westminster HospitalChelsea and Westminster Campus





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

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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.

Initial results from this work have demonstrated that neonatal SARS-CoV-2 infection is uncommon and has good short-term outcomes. This has 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

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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 are using a 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

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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.

How good are neonatal data?

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Research using routinely recorded clinical data is more efficient and cost-effective because it reduces the need for dedicated trial personnel and duplicative collection of data already recorded in the electronic health record. The success of such research thus hinges on the quality of this data. The quality and variation of data will influence the expected power and precision of any trial that utilises it. 

This ongoing work involves defining measures and metrics of quality for trials using routinely recorded neonatal data such as that held in the National Neonatal Research Database. The aim of this work is to better understand how different degrees of missing data influence trial outcomes and to allow missing data to be taken into account at trial inception.

Involving parents in neonatal data

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Parent involvement in neonatal care is a powerful but under-utilised resource.  We want to see whether involving parents more in their baby's routinely recorded electronic health data improves both the parent experience of neonatal care and the quality of data held in the electronic health record.

The WHEAT Trial - A fully Electronic Patient Record embedded neonatal trial

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Trials that use electronic health records have been shown to be practical and efficient in Scandinavia but the feasibility of these trials in NHS neonatal care has yet to be established. 

The WHEAT trial was the first neonatal trial to integrate all trial processes (identification, consent, enrolment, randomisation and data collection) within existing Electronic Patient Record systems. WHEAT also pioneered the use of simplified, opt-out consent, co-designed with parents - demonstrating that such and approach is feasible and acceptable to parents and healthcare professionals.

The purpose of WHEAT (WithHolding Enteral feeds Around Transfusion) is to compare 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 trial is currently recruiting in Australia and aims to be the world's largest individually randomised neonatal trial.

Efficient research regulation

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It is estimated that 85% of all research is wasted. One cause is when the results of research are not useful to doctors; this often happens because the study was not big enough or it did not involve the type of patients seen in the National Health Service (NHS).  A way to make research more representative, more useful to doctors and hence less wasteful is to make it simpler and more efficient.

Several methods have been shown to make clinical trials more efficient, but these are not commonly used in the United Kingdom.  We wanted to know if this was because the way research is regulated prevents these approaches being used. We worked with the Health Research Authority to empirically test how research regulators deal with novel clinical trial methods; this work showed that opt-out consent, streamlined parent co-designed information sheets and trials embedded within electronic patient record systems are acceptable for neonatal clinical trials.


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