Current studies using the NNRD

Funder: NIHR advanced Fellowships 

Title: Babies born at 22-24 weeks gestation in England and Wales 2017-2021 

Chief Investigator: Cheryl Battersby  

Duration: 1st May 2022 - 30th April 2023 

REC reference: 21/EM/0130 

Aims and Objectives
1. To describe the initial management at birth and outcomes for babies born 22+0–24+6 weeks
gestation
i) To report neonatal unit admissions as a proportion of the total infants alive at onset of labour
ii) To describe this geographically across operational delivery networks and over time
2. To determine the impact on neonatal service capacity

Funder: CW+ Health Charity and True Colours Trust

Title: Caring for babies with palliative care needs and/or multiple complex health needs with an uncertain future in England and Wales 2015-2020

Chief Investigator: Cheryl Battersby

Duration: October 2021 – September 2023

REC reference: 21/LO/0024

The study aims to quantify neonatal palliative care needs across England and Wales and is funded through a collaboration between Chelsea and Westminster Hospital, CW+ and True Colours Trust. It will utilise data held in the NNRD to identify babies likely to have palliative care needs within each of the five categories defined in the 2010 BAPM framework on perinatal palliative care. From this, the aim is to provide an indication of neonatal palliative care needs at population level to inform service planning and allocation of resources.

Funder: NIHR Fellowship

Title: neoWONDER: Neonatal Whole Population Data linkage approach to improving long-term health and wellbeing of preterm and sick babies

Chief Investigator: Cheryl Battersby

Duration: 01 Sep 2020 – 31 Aug 2025

REC reference: 21/EM/0130

CAG reference: 21/CAG/0081

Aims: To obtain long-term health and education outcomes for babies born preterm and/or
with surgical conditions by linking the National Neonatal Research Database (NNRD) to
other existing health, educational, and environmental datasets. A de-identified linked dataset
will be analysed:
1) To describe the long-term physical, mental health and educational outcomes
2) To determine the impact of post-discharge exposures (environmental and socio-economic
factors) on modifying later health and educational outcomes
3) To evaluate the impact of neonatal care and interventions on the later health and
educational outcomes

Funder: NIHR Fellowship

Title: Childhood outcomes after perinatal brain injury

Chief Investigator: Dr Pippa Rees

Duration: 1 Sep 2021 - 31 Aug 2024

REC reference: 20/LO/1023

Perinatal brain injury can have wide-ranging devastating consequences. As such, the Department of Health has declared a national ambition to halve the rates of perinatal brain injury by 2030. Whilst advances in neonatal care have dramatically improved short-term survival in this population, there are considerable gaps in our knowledge about the long-term impact of perinatal brain injuries. This study will utilise existing routine data to explore childhood outcomes after perinatal brain injury, in order to understand the prognosis of this population in addition to their health and educational needs, and to ultimately inform health policy and resource provision.

 

Funder: NHS Digital and NHS England

Title: National Pregnancy in Diabetes Audit (part of the National Diabetes Audit - NDA) to link to NNRD data to look at the outcomes and length of stay of babies born to women with pre-existing diabetes

Chief Investigator: Carla Howgate

Duration: Jan 2014 – ongoing (yearly reporting) 

The National Pregnancy in Diabetes (NPID) Audit measures the quality of pre-gestational diabetes care against NICE guideline based criteria and the outcomes of pre-gestational diabetic pregnancy. It answers the following three key questions:

  • Were women with diabetes adequately prepared for pregnancy?
  • Were appropriate steps taken during pregnancy to minimise adverse outcomes to the mother?
  • Did any adverse outcomes occur?

As part of this measurement, and using NNRD data, NHS Digital will extend their investigations to see whether the outcomes of women with pre-existing diabetes and their babies are different to the general population and will also examine if there is a higher instance of admissions to neonatal intensive care, and if these admissions are for longer periods. The findings can then be used to inform changes to the diabetes service for women of childbearing age. 

Link to NPID website: National Pregnancy in Diabetes Audit - NHS Digital

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 – November 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: 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 – March 2023

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

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: 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: 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 - March 2023

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 - ongoing

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: 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: July 2018 - June 2023

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 - December 2023

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: 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.