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

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.


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

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 


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

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/


Optimising newborn nutrition during therapeutic hypothermia: an observational study using routinely collected data - ‌REC Reference: 17/EM/0307

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


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

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


Core Outcomes In Neonatology (COIN)

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. 


iNEO - REC reference: 13/SW/0339

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.


eNewborn - REC Reference: 15/WM/0344

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.


Prevail – REC Reference 14/YH/1202

The PREVAIL study is collaboration between the University College London, Bradford Teaching Hospitals NHS Foundation Trust, University of Liverpool and University of York. It includes a randomised controlled trial to know if antimicrobial and antifungal impregnated peripherally inserted lines prevent infections in very preterm babies and are cost-effective compared with standard lines.

The cost-effectiveness analysis is led by Laura Bojke, Rita Faria and Alessandro Grosso at the University of York. It compares the NHS costs and health outcomes of the two types of catheters. This requires information on the hospital length of stay and resource use for the babies enrolled in PREVAIL during the 6-months follow-up period of the trial. Some of the information on the hospitalisations will be obtained from the National Neonatal Research Database (NNRD). More details can be found in the PREVAIL trial website and in the privacy notice.