1 Pillay T, et al. BMJ Open 2019;9:e029421. doi:10.1136/bmjopen-2019-029421 Open access 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 Thillagavathie Pillay,  1,2 Neena Modi, 3 Oliver Rivero-Arias, 4 Brad Manktelow, 5 Sarah E Seaton, 5 Natalie Armstrong, 5 Elizabeth S Draper, 5 Kelvin Dawson, 6 Alexis Paton, 5 Abdul Qader Tahir Ismail,  1 Miaoqing Yang, 4 Elaine M Boyle 5 To cite: 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:e029421. doi:10.1136/ bmjopen-2019-029421 ► Additional material for this paper are available online. To view these fles, please visit the journal online (http://dx.doi. org/10.1136/bmjopen-2019- 029421). Received 04 February 2019 Revised 19 June 2019 Accepted 09 July 2019 For numbered affliations see end of article. Correspondence to Dr Thillagavathie Pillay; tilly.pillay@nhs.net Protocol © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. 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 Offce 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-specifc 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 fndings 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 fndings and development of recommendations for care. Trial registration number NCT02994849 and ISRCTN74230187. BACKGROUND AND RATIONALE Specialised services for babies in England are delivered by neonatal units managed through Operational Delivery Networks. 1 These are geographical groupings of neonatal units working together in care path- ways, and comprise units that are designated as neonatal intensive care units (NICUs), local neonatal units (LNUs) and special care baby units (SCBUs). 2 3 There were 15 opera- tional delivery networks (ODNs) in England in 2018. 4 NICUs are located within centres that have specialist obstetric and fetoma- ternal medicine services; they have staff and resources to provide tertiary level care for babies of all gestational ages with a wide range and complexity of conditions. LNUs provide care for babies within their local catchment Strengths and limitations of this study ► Scientifc evidence from this study will be used to develop national recommendations for health ser- vice delivery for babies born between 27 and 31 weeks gestation in England. ► This will be guided by clinical outcomes, cost-effec- tiveness, parents’ and staff perspectives. ► As a retrospective population-based observational cohort study, it is subject to selection bias in the as- signment of location of birth of babies. ► Heterogeneity in the quality of care provided within and between local neonatal unit and neonatal inten- sive care unit, is likely, and will be addressed. ► Formal study-driven neurodevelopmental follow-up is not cost-effective in this large cohort, so routine- ly collected data will be used to investigate their outcomes. on April 25, 2020 by guest. 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