Funder: The National Institute for Health Research (NIHR)
Title: Optimising newborn nutrition during therapeutic hypothermia: an observational study using routinely collected data - REC Reference: 17/EM/0307
Chief Investigator: Chris Gale
Duration: September 2017 - June 2019
This is a NIHR funded retrospective study that aims to determine the optimum enteral and parenteral nutrition strategy for infants with Hypoxic Ischaemic Encephalopathy (HIE), during and after therapeutic hypothermia. It is led by Dr Chris Gale, a neonatal consultant at Chelsea and Westminster Hospital NHS Foundation Trust and a Clinical Senior Lecturer at Imperial College London.
The study will use population level data held within the NNRD to examine the association between different feeding strategies and outcomes such as necrotising enterocolitis, and between different parenteral nutrition strategies and outcomes including bloodstream infection. The study will adjust for illness severity using propensity score matching. More details about the study can be found in the protocol
- Optimising newborn nutrition during therapeutic hypothermia: Protocol
- Optimising newborn nutrition during therapeutic hypothermia: REC Ref: 17/EM/0307
- Optimising newborn nutrition during therapeutic hypothermia: HRA approval
Funder: The Medical Research Council
Title: Core Outcomes in Neonatology (COIN)
Chief Investigator: Dr James Webbe
The COIN study is lead by Dr James Webbe, ST4 in Paediatrics, Imperial College and supervised by Professor Neena Modi and Dr Chris Gale, Imperial College London, and Ms Ginny Brunton, UCL Institute of Education. It is a MRC funded project.
The aim of this study is to develop a neonatal Core Outcome Set that are linked to data that are routinely recorded during clinical care. Development and use of a core outcome set will ensure that outcomes of importance to all stakeholders, including patients and parents, are collected and reported in a standard way.
Funder: Kings College, London
Title: Nutrition and respiratory morbidity in extremely premature infants (NutriResp) REC reference: 19/WM/0172
Chief Investigators: Professor Anne Greenough and Dr Theodore Dassios
This is a retrospective five-year whole population study using data currently held within the National Neonatal Research Database (NNRD). It will include all infants born less than twenty-eight completed weeks of gestation and explore the relationship of growth failure and respiratory morbidity by analysing parameters relating to birth and discharge weight and duration of mechanical ventilation. Other information analysed will be variables that can be grouped into nutritional and respiratory outcomes such as home oxygen requirement and duration of parenteral nutrition.
Funder: The University of Nottingham
Title: Respiratory outcomes of infants <32 weeks gestation – risk factors for bronchopulmonary dysplasia (PremRO) REC ref 19/YH/0115)
Chief Investigator: Dr Don Sharkey
This study will look at what are the current risk factors associated with bronchopulmonary dysplasia (BPD) in a recent UK population of preterm infants?
Funder: Shire pharmaceuticals
Title: Retrospective Validation of the PREMature Infant Index (PREMII) using a Real-World Database: REC reference 18/LO/1619)
Chief Investigator: Sisi Wang (ICON plc)
This a research study entitled ‘Retrospective Validation of the PREMature Infant Index (PREMII) using a Real-World Database’. The purpose of this study is to validate a clinician reported outcome instrument, the PREMature Infant Index (PREMII), developed by Shire, which assesses an infant’s overall functional status. This retrospective study is designed to validate the PREMII score at 36 week of postmenstrual age with an infant’s length of stay in the neonatal unit using a real-world database.
Data intensive research using national database: Predictors of adverse outcome in cooled infants with hypoxic-ischaemic encephalopathy (HIE) and perinatal infection - REC Reference: 18/NW/0377
This study is a collaborative study between researchers in the GW4 (University of Bristol, Cardiff University, Exeter University), University of Dusseldorf and Imperial College led by Dr Ela Chakkarapani at the University of Bristol.
The study will use the data of infants who underwent cooling therapy for neonatal encephalopathy held in the National Neonatal Research Database (the NNRD). The team will investigate the effect of pre-sensitisation with infection or culture-positive sepsis on death and adverse outcomes. This will determine the predictors of death and adverse outcomes in cooled infants exposed to infection.
- Effect of cooling on HIE with perinatal infection invitation letter
- Effect of cooling on HIE with perinatal infection protocol
- Effect of cooling on HIE with perinatal infection HRA approval
- Effect of cooling on HIE with perinatal infection REC ref: 18/NW/0377
- Privacy Notice hypoxic-ischaemic encephalopathy (HIE) and perinatal infection
Drug utilization patterns in neonatal units in the UK: a retrospective pharmaco-epidemiological study, The COMMON study; COMmonly used Medicines On Neonatal units in the UK- REC Reference: 18/YH/0209
The COMMON study aims to identify the most commonly used drugs in neonatal units in the UK, including drugs and other products used in special circumstances (e.g. at delivery, during resuscitation, blood products and parenteral nutrition) and to determine the change in pattern of drug use in neonatal units in the UK over the last 8 years whilst examining variations in drug use by gestation, birth weight, neonatal unit level of care and inter-hospital variation.
- The COMMON Study invitation letter
- The COMMON Study protocol
- The COMMON Study REC reference: 18/YH/0209
- The COMMON Study HRA approval
- The COMMON Study privacy notice.
SPRING; Study of preterm birth and neurodevelopmental genes: a pilot investigation - REC Reference: 16/WA/0324
The SPRING study is a collaboration between Professor Anita Thapar (lead; Cardiff University), Professor Michael O’Donovan (Co-investigator; Cardiff University), Professor Neena Modi (Co-investigator; Imperial College/NDAU) and Dr Hilary Wong (Co-investigator; University of Cambridge).
The purposes of the study are to test one hypothesis that preterm birth and neuropsychiatric disorders share the same genetic risk factors (objective 1) and to conduct a pilot investigation that will inform future large-scale studies utilising the NNRD to investigate the relationships between very preterm birth, genetics and neuropsychiatric disorders (objective 2).
Prevail - REC Reference: 14/LO/1965
The Prevail study is led by Dr Sam Oddie, Consultant Neonatologist Bradford Royal Infirmary. The study will link data from the National Neonatal Research Database (NNRD) with data submitted by microbiology laboratories to PHE. The purpose is to monitor risk-adjusted rates of bloodstream infection across neonatal units in England in order to determine the generalisability of outcomes of the NIHR funded PREVAIL study (PREVenting infection with Antimicrobial Impregnated Long lines). The data will be sent to PHE where linkage with laboratory data will take place resulting in the creation of a national resource comprising NNRD data linked with the date and results of blood cultures submitted by microbiology laboratories to PHE.
- PREVAIL generalisability study letter to NNU leads (pdf)
- PREVAIL Generalisability protocol (pdf)
- PREVAIL Generalisability Appendix 1 (pdf)
- Prevail REC Ref 14/LO/1965 (pdf)
The impact of inter-hospital transportation: Neonatal outcomes and implications for
families - REC reference: 17/LO/1822
The study is led by Dr Don Sharkey, Faculty of Medicine and Health Sciences, School of Medicine, Division of Child Health,
Queen’s Medical Centre, Nottingham.
The study will use population level data held within the NNRD to examine the patterns of transfers in the UK in recent years and the potential impact this has on families in terms of the time away from their booking hospital. The study will also look at a defined group of babies, those with hypoxic-ischaemic encephalopathy, to see how delivery of therapeutic hypothermia is evolving in the UK and if there are any changes in short-term outcomes observed with inter-hospital transfer.
Fortified mother’s own and donor human milk on growth and health outcomes at discharge in preterm infants in Scotland: retrospective cohort analysis - REC Reference: 17/NS/0052
This study is led by Mrs Wesam Alyahya, PhD student in Human Nutrition, University of Glasgow and supervised by Prof Christine Edwards, Professor of Nutritional Physiology, at Human Nutrition in the School of Medicine Dentistry and Nursing University of Glasgow.
The aim of the study is to use anonymised data held in the National Neonatal Research Database (NNRD) to measure the association between using fortified donor human milk (DHM) and outcomes such as growth, length of hospital stays and infection in babies born at less than 32 weeks gestation in Scotland.
- Fortified Milk Study cover letter
- Fortified Milk Study Protocol
- Fortified Milk HRA approval
- Fortified Milk REC approval
Comparison of admission rates to neonatal units between pulse oximetry screening and non-pulse oximetry screening Units - REC reference: 17/LO/0332
The pulse oximetry study is led by Dr Andrew Ewer, Professor of Neonatal Medicine, University of Birmingham with Co-investigators: Prof Tracy Roberts, Dr Karen Pickering, Dr Pelham Barton and Dr Christopher Gale.
- Pulse oximetry study invitation letter
- Pulse oximetry protocol
- Pulse oximetry REC Ref 17/LO/0332
- Pulse oximetry Letter of HRA Approval
Inhaled nitric oxide (iNO) - REC reference: 16/WS/0228
The iNO (Inhaled nitric oxide) study’s Chief Investigator is Nimish Subhedar, Neonatologist, Liverpool Women’s Hospital. Dr Chris Gale, Senior Lecturer, Imperial College, London and Eugene Statnikov, Senior Data Manager, Neonatal Data Analysis Unit, Imperial College, London are Co-investigators.
Inhaled nitric oxide (iNO) is widely used in the treatment of hypoxaemic respiratory failure and persistent pulmonary hypertension of the newborn. Although a well-established therapy in term and near-term infants, its use in preterm infants < 34 weeks’ gestation remains controversial. Population based data indicates that there is wide variation in administration rates amongst US hospitals, but there is no equivalent data from the UK or mainland Europe [1-4]. Data from individual centres and multicentre studies suggests that the use of iNO is increasing in recent years, especially in preterm infants, despite the lack of a clear evidence base in this population.
The iNO study aims to describe hospital variation in patient demographics and treatment rates relating to the use of inhaled nitric oxide in term and preterm infants admitted to neonatal units in England.
Estimating incidence of Group B Streptococcus-associated neonatal encephalopathy - REC reference: 17/EE/0018
- Group B Streptococcus invitation letter
- Group B Streptococcus protocol
- Group B Streptococcus REC ref 17/EE/0018
- Group B Streptococcus letter of HRA approval
Acute postnatal transfer and outcomes in extremely preterm babies” research study - REC reference : 16/EM/0351
This study is lead by Chief Investigator: Dr Christopher Gale with Co-investigators: Dr Kjell Helenius and Professor Liisa Lehtonen (Turku University Hospital, Finland) Professor Neena Modi and Statistician: Dr Nicholas Longford. The study aims to determine the impact of acute postnatal transfer (within 48 hours of birth) on mortality and morbidity among extremely preterm infants.
- Acute postnatal transfer invitation letter
- Acute postnatal transfer protocol
- Acute postnatal transfer REC Ref 16/EM/0351
- Acute postnatal transfer Letter of HRA approval
NeoNet – REC Reference: 15/NW/0503
The aim of NeoNet, led by Professor Martin Pitt, Associate Professor of Healthcare Modelling and Simulation, University of Exeter Medical School, is to develop a computer model of demand and capacity for neonatal care in England. The model runs through simulated time and predicts variation in unit workload, periods of overload and unit closure, number and distances of required transfers, and distances from the parent’s home location to the location of care of the infant. Infants are born in the model with varying needs; they may access specialist surgical/cardiac services, intensive care, high dependency care, special care and transitional care. The number, location, type and size of units may be varied and the impact on service providers and parents predicted. This national model builds on a previous regional model developed for the South West Peninsula Region.
- NDAU circulation letter (pdf)
- NeoNet agreement (pdf)
- Neonet Protocol (pdf)
- NeoNet REC Ref 15/NW/0503 (pdf)
The NIHR Final Report for NeoNet "A framework to address key issues of neonatal service configuration in England: the NeoNet multimethods study" can be downloaded here https://www.journalslibrary.nihr.ac.uk/hsdr/hsdr06350/#/abstract
UK Neonatal Collaborative Necrotising Enterocolitis Study: using operational clinical data captured electronically at the point of care for surveillance and research: UKNC - NEC Study - REC ref: 11/LO/1430
Lead: Dr Cheryl Battersby, Imperial College, email@example.com
Background: There is a poor understanding of the epidemiology, multi-factorial aetiology and pathophysiology of NEC. Strategies for prevention remain elusive, making this an issue of prime importance for neonatal care. There are scant population incidence data, most previous studies have reported by birth weight categories rather than gestational age, and case-definitions have been inconsistent. Interventional studies require good baseline data and an objective case-definition.
- To establish an objective case-definition for NEC
- To determine the population incidence of NEC in England
- To identify enteral-feed related factors that precede onset of NEC in order to inform the design of future interventional randomised controlled trials
- UKNC - NEC Protocol
- UKNC - NEC REC Ref: 11/LO/1430
- UKNC - NEC PIS
- UKNC - NEC study poster
- UKNC - NEC FAQ's
Bliss Staffing Study: Neonatal Economic, Staffing and Clinical Outcomes Project (NESCOP)
The DIN Project: Down syndrome In Neonatal units.
Modelling neonatal care pathways: costs and consequences for the future
Lead: Sarah Seaton, University of Leicester
- Modelling neonatal care pathways: invitation letter
- Modelling neonatal care pathways: information leaflet
- Modelling neonatal care pathways: REC ref: 14/NW/0349
Gentamicin, Genetic Variation and Deafness in Preterm Children (Mitogent)
Leads: Dr Maria Bitner-Glindzicz and Dr Shamima Rahman, UCL Institute of Child Health
British Paediatric Surveillance Unit Neonatal Exchange Blood Transfusion (EBT):
Lead: Dr Ruth Gottstein, Central Manchester University Hospitals NHS Foundation Trust
- Neonatal Exchange Blood Transfusion protocol
- Neonatal Exchange Blood Transfusion (EBT) patient information sheet
- Neonatal Exchange Blood Transfusion (EBT) REC ref: 13/NW/0063
- RCPCH BPSU Findings