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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.
BMJ Open 2019; 9(8):e029421BO

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.

Authors+Show Affiliations

Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK tilly.pillay@nhs.net. School of Medicine and Clinical Practice, University of Wolverhampton Faculty of Science and Engineering, Wolverhampton, UK.Department of Neonatal Medicine, Imperial College London, London, UK.Nuffield Department of Population Health, University of Oxford, Oxford, UK.Department of Health Sciences, University of Leicester, Leicester, UK.Department of Health Sciences, University of Leicester, Leicester, UK.Department of Health Sciences, University of Leicester, Leicester, UK.Department of Health Sciences, University of Leicester, Leicester, UK.Parent Representative, BLISS National Charity for Babies Born Premature or Sick, London, UK.Department of Health Sciences, University of Leicester, Leicester, UK.Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK.Nuffield Department of Population Health, University of Oxford, Oxford, UK.Department of Health Sciences, University of Leicester, Leicester, UK.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31444186

Citation

Pillay, Thillagavathie, et al. "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." BMJ Open, vol. 9, no. 8, 2019, pp. e029421.
Pillay T, Modi N, Rivero-Arias O, et al. 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. BMJ Open. 2019;9(8):e029421.
Pillay, T., Modi, N., Rivero-Arias, O., Manktelow, B., Seaton, S. E., Armstrong, N., ... Boyle, E. M. (2019). 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. BMJ Open, 9(8), pp. e029421. doi:10.1136/bmjopen-2019-029421.
Pillay T, et al. 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. BMJ Open. 2019 Aug 22;9(8):e029421. PubMed PMID: 31444186.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Pillay,Thillagavathie, AU - Modi,Neena, AU - Rivero-Arias,Oliver, AU - Manktelow,Brad, AU - Seaton,Sarah E, AU - Armstrong,Natalie, AU - Draper,Elizabeth S, AU - Dawson,Kelvin, AU - Paton,Alexis, AU - Ismail,Abdul Qader Tahir, AU - Yang,Miaoqing, AU - Boyle,Elaine M, Y1 - 2019/08/22/ PY - 2019/8/25/entrez PY - 2019/8/25/pubmed PY - 2019/8/25/medline KW - health economics KW - neonatal intensive & critical care KW - neonatology KW - organisation of health services SP - e029421 EP - e029421 JF - BMJ open JO - BMJ Open VL - 9 IS - 8 N2 - 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. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/31444186/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 L2 - http://bmjopen.bmj.com/cgi/pmidlookup?view=long&pmid=31444186 DB - PRIME DP - Unbound Medicine ER -