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Optimising neonatal service provision for preterm babies born between 27 and 31 weeks gestation in England (OPTI-PREM), using national data, qualitative research and economic analysis: a study protocol
  1. Thillagavathie Pillay1,2,
  2. Neena Modi3,
  3. Oliver Rivero-Arias4,
  4. Brad Manktelow5,
  5. Sarah E Seaton5,
  6. Natalie Armstrong5,
  7. Elizabeth S Draper5,
  8. Kelvin Dawson6,
  9. Alexis Paton5,
  10. Abdul Qader Tahir Ismail1,
  11. Miaoqing Yang4,
  12. Elaine M Boyle5
  1. 1 Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK
  2. 2 School of Medicine and Clinical Practice, University of Wolverhampton Faculty of Science and Engineering, Wolverhampton, UK
  3. 3 Department of Neonatal Medicine, Imperial College London, London, UK
  4. 4 Nuffield Department of Population Health, University of Oxford, Oxford, UK
  5. 5 Department of Health Sciences, University of Leicester, Leicester, UK
  6. 6 Parent Representative, BLISS National Charity for Babies Born Premature or Sick, London, UK
  1. Correspondence to Dr Thillagavathie Pillay; tilly.pillay{at}nhs.net

Abstract

Introduction In England, for babies born at 23–26 weeks gestation, care in a neonatal intensive care unit (NICU) as opposed to a local neonatal unit (LNU) improves survival to discharge. This evidence is shaping neonatal health services. In contrast, there is no evidence to guide location of care for the next most vulnerable group (born at 27–31 weeks gestation) whose care is currently spread between 45 NICU and 84 LNU in England. This group represents 12% of preterm births in England and over onr-third of all neonatal unit care days. Compared with those born at 23–26 weeks gestation, they account for four times more admissions and twice as many National Health Service bed days/year.

Methods In this mixed-methods study, our primary objective is to assess, for babies born at 27–31 weeks gestation and admitted to a neonatal unit in England, whether care in an NICU vs an LNU impacts on survival and key morbidities (up to age 1 year), at each gestational age in weeks. Routinely recorded data extracted from real-time, point-of-care patient management systems held in the National Neonatal Research Database, Hospital Episode Statistics and Office for National Statistics, for January 2014 to December 2018, will be analysed. Secondary objectives are to assess (1) whether differences in care provided, rather than a focus on LNU/NICU designation, drives gestation-specific outcomes, (2) where care is most cost-effective and (3) what parents’ and clinicians' perspectives are on place of care, and how these could guide clinical decision-making. Our findings will be used to develop recommendations, in collaboration with national bodies, to inform clinical practice, commissioning and policy-making. The project is supported by a parent advisory panel and a study steering committee.

Ethics and dissemination Research ethics approval has been obtained (IRAS 212304). Dissemination will be through publication of findings and development of recommendations for care.

Trial registration number NCT02994849 and ISRCTN74230187.

  • neonatology
  • organisation of health services
  • neonatal intensive & critical care
  • health economics

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Footnotes

  • Contributors TP developed the idea for the project and developed the protocol in conjunction with EMB, and the Opti-Prem collaborating team. NM contributed to protocol development and provided guidance regarding NNRD data utilisation. TP, EMB and AQTI developed the concepts around workstream 2. TP and EMB are supervising AQTI’s PhD project around this workstream. BM and SES developed the statistical methodology for the project. OR-A contributed to the protocol development, the statistical methodology for workstreams 2 and 3, and the study design of the cost-effectiveness analysis in workstream 3. MY contributed to the development of the statistical methodology for workstreams 2 and 3 and contributed to the study design of the economic analysis of workstream 3. NA and AP developed the ethnographic element (workstream 4) of the project. ESD provided epidemiological and overall support for the protocol. KD is the lead for the BLISS parent panel and has provided support and counsel at all stages of the project thus far.

  • Funding This work is supported by the National Institute for Health Research, Health Services and Delivery Research Stream, project number 15/70/104 CRN accrual was approved by the NIHR for the period (1 August 2017 to 31 August 2018).

  • Competing interests None declared.

  • Ethics approval Research ethics approval has been obtained through the national Integrated Research Application System (IRAS, reference number 212 304 and research ethics committee reference number 17/NE/0800). For workstreams 1, 2, 3 and 5, a proportionate review was undertaken. For workstream 4, research ethics approval was obtained together with R&D approval from the individual Trusts at which the interviews and observations will be conducted.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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