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

Title: Long term follow-up of Azithromycin Therapy for Chronic Lung Disease of Prematurity. The AZTEC 2 (AZithromycin ThErapy for Chronic lung disease 2) - REC reference: 19/WA/0267 

Chief Investigator: Professor Sailesh Kotecha 

Duration: March 2021 - June 2025 

The following research questions will be investigated:

1. Does azithromycin improve the long term respiratory outcomes of preterm-born children at 1 and 2 years of corrected age?

2. Does azithromycin improve the long term neurodevelopmental outcomes of preterm-born children at 1 and 2 years of corrected age?


Funder: The National Institute for Health Research (NIHR) 

Title: Timing of Stoma Closure in Neonates (ToSCiN) Study - REC reference: 20/LO/1227 

Chief Investigator: Dr Nick Lansdale 

Duration: March 2020 – February 2022

This study is part of an NIHR funded pilot study Timing of Stoma Closure in Neonates (ToSCiN) study https://www.fundingawards.nihr.ac.uk/award/NIHR128617 to help determine whether such a trial would be feasible. 

The aim of this component of the Timing of Stoma Closure in Neonates (ToSCiN) Study is to use data from an already established database, the UK National Neonatal Research Database (NNRD) to help understand current practices and factors associated with timing of stoma closure. This information will help determine feasibility and design of a trial.


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: The National Institute for Health Research (NIHR) 

Title: Modelling the transition from neonatal to paediatric care: a data linkage study - REC reference: 20/EE/0220 : CAG reference: 20/CAG/0110 

Chief Investigator: Sarah Seaton 

Duration: Sep 2020 – August 2023

For further information about this study, including the study privacy notice, please click here 


 

Funder: The National Perinatal Epidemiology Unit.

Title: Neonatal Complications of Coronavirus Disease (COVID-19) Study - REC reference: 20/NE/0107 : CAG reference: 20/CAG/0058

Chief Investigator: Professor Jennifer J Kurinczuk

Duration: March 2020 – December 2021

So far we have very little information about how the SARS-CoV-2 virus affects mothers and newborn babies and it is not clear how best to care for the mothers and babies affected. So far we have very little information about how babies get SARS-CoV-2, whether it transmits from mothers to their babies while they are still pregnant, during labour and birth, or whether the infection occurs following birth. If we carry out research now, it will mean that we can start to give the best care to mothers and babies and the best advice to pregnant women about the effects of the coronavirus on them and their baby.

This study focuses on collecting information about newborn babies who have the coronavirus or who are born to mothers who have tested positive for coronavirus.

This information will help us to understand:

  1. How babies get SARS-CoV-2
  2. What happens to babies when their mother has SARS-CoV-2
  3. What treatments are effective in helping babies with SARS-CoV-2to get better
  4. What happens to babies in the longer term

Covid-19 in pregnancy


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 2020 to October 2020

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: 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 2020 to October 2020

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: 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: University of Hull

Title: An investigation to determine if vaccinations are delayed in preterm infants, and the factors associated with vaccination timeliness in preterm infants. (Vaccination timeliness in preterm infants) -  REC reference: 19/EM/0351 : CAG reference: 19/CAG/0197

Chief Investigator: Helen Sisson

Duration: January 2020 – December 2023

Preterm infants are particularly vulnerable to infections, and an awareness of vaccination delays in this population would enable services to effectively target efforts and resources. The study aims to establish if infants born prematurely experience delays in receiving routinely scheduled primary vaccines, and any characteristics associated with timeliness.


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: CLARHC - West

Title: National PReCePT (Prevention of cerebral palsy in pre-term labour) Programme Evaluation - FREC ID: 84582

Chief Investigator: Prof John Macleod

Duration: January 2019 – December 2022

This evaluation of the NPP aims to assess whether the AHSN-sponsored roll-out of the standard PReCePT Quality Improvement (QI) intervention improves the uptake of the provision of MgSO4 in preterm babies (<30 weeks G.A.), and to identify the factors that support its implementation and sustainability.

Funder: CLARHC - West

Title: The PReCePT study

Chief Investigator: Dr Karen Luyt

Duration: January 2019 – December 2022

The study aims to assess whether an enhanced Quality Improvement (QI) intervention improves the uptake of the provision of magnesium sulphate to preterm babies (<30 weeks gestation) in maternity units across England between September 2018 and September 2019, compared to the uptake in units solely under the National Precept Programme (NPP, control units).


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: NIHR Imperial Biomedical Research Centre ITMAT Funding Award/The Medical Research Council 

Title: DEEPNEO: A machine-learning approach to describe variations in clinical practice and patient outcomes in neonatal units in England and Wales. REC reference:  16/LO/1093 

Chief Investigator: Professor Neena Modi 

Duration: September 2019 – December 2022

  1. The objective is to provide demonstration of a planned pathway to applications to deliver
  2. clinical trials, industry-led studies and public-sector evaluations to improve newborn care more rapidly and at lower cost, by applying big-data analytics to a mature high-quality clinical registry, the National Neonatal Research Database (NNRD); and publish key methodological and healthcare insights in high impact journals.

Funder: The National Institute for Health Research (NIHR) 

Title: The POOL Study: Establishing the safety of waterbirth for mothers and babies: A cohort study with nested qualitative component - REC reference: 18/WA/0291, CAG reference: 18/CAG/0153 

Chief Investigator: Julia Sanders 

Duration: December 2018 - July 2021

The main analysis of the Pool study is all women who meet NICE1 criteria for being at low risk of complications who use water immersion during labour. Primary objective is to establish whether for low risk women who use a pool during labour, waterbirth, compared to leaving a pool prior to birth, is as safe for mothers and infants.


Funder:  The National Institute for Health Research (NIHR) 

Title: A Feasibility Study of no routine Gastric residual volume measurement in mechanically ventilated Infants and Children: the GASTRIC study - UWE REC REF No: HAS.18.04.144 

Chief Investigator: Lyvonne Tume 

Duration: April 2018 - 

The GASTRIC feasibility study will meet the commissioning brief by the HTA, to answer the question: Is it feasible to conduct a study identifying the impact of not measuring gastric residual volume on clinical outcomes in mechanically ventilated infants and children receiving enteral feeding?


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 Medical Research Council 

Title: Outcomes following early parenteral nutrition use in very preterm neonates - REC Reference: 18/NI/0214  

Chief Investigator: Chris Gale 

Duration: March 2016 - February 2023

The aim of the study is to use anonymised data held in the NNRD to measure the association between early use of parenteral nutrition (within the first 7 days) and outcomes such as mortality and growth, in babies born between 30 and 33 weeks gestation.

Premature neonates are one of the largest users of parenteral nutrition in the NHS.  While there has been a great deal of research in this area, there remains uncertainty over exactly which babies will benefit from early parenteral nutrition.  Recent randomised controlled trials in critically unwell children and adults found that use of parenteral nutrition within the first week of admission to intensive care was detrimental.  The relevance of these studies to a population of neonatal patients is uncertain, but by using the population level data stored in the NNRD the study will explore the association between use of parenteral nutrition in the first week of postnatal life and important outcomes in a contemporary cohort of infants, with adjustment for illness severity. 

The Chief Investigator is Dr Chris Gale, Senior Clinial Lecturer, Imperial College London and Neonatal consultant Chelsea and Westminister NHS Foundation Trust.  The study is being co-ordinated by Dr James Webbe,Clinical Research Fellow in Neonatal Medicine, Imperial College London.


Funder: The Medical Research Council 

Title: WithHolding Enteral feeds Around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates; The WHEAT TRIAL REC reference: 18/LO/0900  

Chief Investigator: Chris Gale 

Duration: 

WHEAT stands for WithHolding Enteral feeds Around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates.  It is a multi-centre, randomised point of care trial.  This means that WHEAT uses information that is already being collected by doctors and nurses as part of day to day care, which makes it much simpler and easier to take part in.

There are two aims of WHEAT:

  1. To demonstrate that a point of care trial design is a simpler, easier and more efficient way to carry out clinical trials, please see the video below for more information.
  2. To see whether withholding milk feeds before, during and after blood transfusion in preterm infants reduces the risk of necrotising enterocolitis.

The Chief Investigator is Dr Chris Gale, Senior Clinial Lecturer, Imperial College London and Neonatal consultant Chelsea and Westminister NHS Foundation Trust. 

https://www.npeu.ox.ac.uk/wheat/wheat-trial 


Funder: Chiesi 

Title: The effect of surfactant dose on outcomes in preterm infants with Respiratory Distress Syndrome - OPTI-SURF - REC Reference: 18/WM/0132 

Chief Investigator: Kevin Goss 

Duration: April 2018 - March 2022

OPTI-SURF is a prospective observational study using de-identified data from the Neonatal Network Research Database (NNRD) supplemented by additional information on dose, method of surfactant administration and dosing frequency. OPTI-SURF aims to assess whether the dose and method of administration of surfactant given to preterm infants with respiratory distress syndrome (RDS) affects neonatal outcomes. The Chief Investigator is Dr Kevin Goss, Consultant Neonatologist at Leeds Children’s Hospital and Honorary Senior Lecturer at the University of Leeds.

http://www.leedsth.nhs.uk/research/clinical-trials/paediatric-research/optisurf/


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 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 Medical Research Council

Title: Core Outcomes in Neonatology (COIN)

Chief Investigator: Dr James Webbe 

Duration:

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: Canadian Institute of Health Research

Title: iNEO - REC reference: 13/SW/0339

Chief Investigator: Prakesh Shah (Canada) Co-I Neena Modi (UK)

Duration: November 2012 - ongoing

The foundation of this research programme is the establishment of the international Network for Evaluating Outcomes (iNeo) in neonates. It is led by Professor Prakesh S Shah, Departments of Paediatrics and HPME, Mount Sinai Hospital and University of Toronto. iNEO will be used to examine and ultimately improve outcomes, care processes, and health care delivery for very low birth weight infants (VLBW) through international collaborative learning. iNeo currently includes collaborators from Australia, New Zealand, Canada, Israel, Japan, Spain, Sweden, Switzerland, and the UK. The overall aims of the iNeo programme are to:

  1. Compare outcomes at country level for VLBW infants
  2. Identify country-specific characteristics that may underlie variations in outcomes
  3. Train and support junior researchers in neonatal-perinatal health services research
  4. Identify clinical and organisational improvements relevant to Canadian neonatal care
  5. Implement and continually evaluate the impact of data-informed and evidence-linked clinical and organisational practice changes in Canadian neonatal units

Analysis was originally for data from 2008 – 2010 but after a minor amendment to the Research ethics analysis will be of data from 2008 – 2015.


Funder: Bayer (Previously Baillet-Latour Fund)

Title: eNewborn - REC Reference: 20/LO/10046 (previously 15/WM/0344)

Chief Investigator: Prof Neena Modi (previously Prof Dominique Haumont)

Duration: June 2015 – ongoing

eNewborn is a European wide benchmarking and evaluation programme focusing focus on babies ≤32 weeks’ gestation. It is led by Professor Dominique Haumont, University of Brussels. Benchmarking will take place at the level of Neonatal Unit, Neonatal Operational Delivery Network, Nation (Scotland, Wales, England), or country (UK). Benchmarking at Neonatal Operational Delivery Network level will require participation by all Neonatal Units within the Network. No patient, neonatal unit or neonatal network identifiers will be included. Neonatal Units and Networks will be assigned a unique “eNewborn®” code.