Completed studies using the NNRD

 

Funder: NIHR Research Professorship 

Title: An investigation of the neonatal burden of disease of hypertensive disorders of pregnancy: a population-based study using the National Neonatal Research Database

Chief Investigator: Professor Lucy Chappell

Duration: March 2021 - February 2022

The aim of this study is to understand the neonatal burden of maternal hypertensive disorder of pregnancy disease as captured in neonatal unit electronic health records over a 8 year period  (2012-2020). Objectives are:

  1. quantify the proportion of all babies admitted to neonatal units born to women with a hypertensive disorder of pregnancy
  2. describe the national neonatal morbidity, mortality and resource use of babies admitted to neonatal units born to women with a hypertensive disorder of pregnancy
  3. examine ethnic disparities in neonatal outcomes of babies admitted to neonatal units born to women with hypertensive disorders of pregnancy.

 Funder: Prolacta BioScience

Title: Budget impact analysis of exclusive human milk diet for very premature babies in England - REC reference: 20/PR/0759

Chief Investigator: Christopher Sampson 

Duration: January 2021 – June 2021 

The purpose of the analysis is to inform resource allocation decision-making in England.

Human milk based fortifiers are commercially available and could be adopted as part of routine care in the NHS. Evaluative research – in the form of a clinical trial – is currently underway to assess the effectiveness of this care strategy, as well as the associated resource use and resulting costs.

In addition to estimates of clinical effectiveness, decision-makers need to understand the budget impact of their decisions. By building on the findings of clinical trials, this analysis will provide estimates of:

  1. The estimated difference in the length of stay at different levels of specialist care.
  2. The estimated difference in the number of key procedures.
  3. The incremental cost – per patient per day – of commercial human milk supplementation in England.
  4. The total budget impact of commercial human milk fortification in England.

Funder: Imperial College

Title: Management of Patent Ductus Arteriosus (PDA) in babies admitted to UK neonatal units: a population-based study using the National Neonatal Research Database - REC reference: 20/LO/0825

Chief Investigator: Dr Cheryl Battersby

Duration: May 2021 to October 2021

The aim is to describe the management of patent ductus arteriosus in preterm babies admitted to neonatal units in England and Wales over a 10 year period (2010-2019). Objectives are:

  1. To quantify the number and proportion of preterm babies, born <32 weeks gestation, who receive medical and/or surgical intervention for PDA. 
  2. To describe the infant background and clinical characteristics at the time of medical or surgical PDA intervention and compare them to babies within similar gestational age (GA) groups who did not have an intervention.
  3. To determine the postnatal age of medical or surgical PDA intervention.
  4. To describe the outcomes of babies treated for PDA (including BPD, NEC, mortality, ventilatory days, brain injury, retinopathy of prematurity) and compare with babies of similar gestational age and neonatal unit with babies those that did not receive PDA intervention
  5. To explore the presence of temporal trends and geographical variation in PDA management for the aims 1-4.

Funder: The National Institute for Health Research (NIHR) Health Technology Assessment (HTA) 

Title: The clinical and cost-effectiveness of testing for Group B Streptococcus: a cluster randomised trial with economic and acceptability evaluations (GBS3) - REC Reference: 19/EM/0253

Chief Investigator: Professor Jane Daniels  

Duration: April 2020 - April 2022

Does routine testing of women for Group B Streptococcus (GBS) colonisation either in late pregnancy or during labour reduce the occurrence of early-onset neonatal sepsis, compared to the current risk factor based strategy?

Funder: Imperial College

Title: Outcomes of early versus late commencement of parenteral nutrition in very preterm infants - REC reference 16/LO/1093

Chief Investigator: Dr Sabita Uthaya

Duration: May 2021 to October 2021

The study is designed to explore the impact on outcomes of the timing of parenteral nutrition commencement in very preterm babies in England and Wales. The safety of early parenteral nutrition, although now a standard of care, in very preterm babies has not been previously investigated.

Funder: University of Southampton 

Title: Re-Growth Reassessing the growth of infants born below 32 weeks’ gestation in the UK, 2014-2018. REC reference: 20/SC/0073 

Chief Investigator: Mark Johnson 

Duration: May 2020 – May 2021

Re-Growth will reassess the early growth pattern of very preterm infants born in the UK.

Funder: The Medical Research Council

Title: MICA: A partnership to extend the research utility of a source of real-world health data.

Chief Investigator: Professor Neena Modi

Duration: April 2020 – September 2022

The UK National Neonatal Research Database, is a partnership between, the Neonatal Data Analysis Unit (the data controllers of the NNRD), the Institute for Translational Medicine and Therapeutics Data Science Group (ITMAT - DSG) Imperial College, NHS Digital (NHSD), The National Perinatal Epidemiology Unit (NPEU) University of Oxford, Bliss (the baby charity), Health Data Research UK (HDR UK) and the Strategic Intelligence Alliance (SIA) in Healthcare Ltd. The aim of the partnership is to extend the already wide research utility of a mature, award-winning, national resource of real-world data, the UK National Neonatal Research Database (NNRD).

The partners 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. The partnership 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. 

Funder: The Medical Research Council 

Title: Tracking the Impact of Gestational Age on Health, Educational and Economic outcomes: a Longitudinal Record Linkage Study – (TIGAR) - REC reference: 15/SW/0294 

Chief Investigator: Oliver Rivero Arias 

Duration: May 2017 - August 2021

The overall aim of the study is to investigate the effect of gestational age on health, educational and economic outcomes up to age 11 years. the study will estimate the NHS health care costs of the original birth admission and subsequent readmissions up to 10 years follow-up of all babies born in England in 2005/2006 across all gestational age groups.

Funder: Prolacta 

Title: Interactions between the diet and gut microbes, metabolism and body composition in preterm infants (INDIGO) - REC reference: 17/NE/0169 

Chief Investigator: Neena Modi 

Duration: October 2017 - June 2021

Study objectives of Indigo are to evaluate whether an exclusive human milk diet compared with exposure to cow’s milk-based products results in differences in a) gut bacteria (types and diversity, b) stool and urine metabolites and c) body composition.

Funder: The National Institute for Health Research (NIHR) 

Title: OPTI-PREM: Optimising neonatal service provision for preterm babies born between 27 and 31 weeks of gestation using national data, qualitative research and economic analysis - REC Reference: 17/NE/0080 

Chief Investigator: Thillagavathie Pillay 

Duration: January 2017 – August 2021

The OPTI-PREM research project is a collaboration between Dr Thillagavathie Pillay (Chief investigator) the Royal Wolverhampton NHS Trust, Professor Elaine Boyle, Professor Elizabeth Draper, Natalie Armstrong, Brad Manktelow and Sarah Seaton (co-investigators) Universities of Leicester, Oliver Rivero-Arlas (co-investigator) University of Oxford, Professor Neena Modi (co-investigator) Imperial College and the NDAU. OPTI-PREM is funded by the NIHR Health Services and Delivery Research programme to investigate the optimal place of care for preterm babies born between 27+0 to 31+6 weeks of gestation (‘born at 27-31 weeks’) in England.

Optiprem website

twitter feed can be found at @Opti_Prem 

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

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.

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.

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.

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.

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.

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

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.

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.

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, c.battersby@imperial.ac.uk

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.

 Overall aims

  1. To establish an objective case-definition for NEC
  2. To determine the population incidence of NEC in England
  3. To identify enteral-feed related factors that precede onset of NEC in order to inform the design of future interventional randomised controlled trials

Incidence and enteral feed antecedents of severe neonatal necrotising enterocolitis across neonatal networks in England, 2012–13: a whole-population surveillance study

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

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