Optimising neonatal service provision for preterm babies born between 27 and 31 weeks gestation in England (OPTIPREM), using national data, qualitative research and economic analysis: a study protocol

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 a third of all neonatal unit care days. Compared to those born at 23-26 weeks gestation they account for four times more admissions and twice as many NHS 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 a NICU versus a 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 a)whether differences in care provided, rather than a focus on LNU/NICU designation, drives gestation-specific outcomes, b)where care is most cost-effective, c)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. Strengths and Limitations of this Study Strengths  Scientific evidence from this study will be used to develop national recommendations for health service delivery for babies born between 27-31 weeks gestation in England.  This will be guided by clinical outcomes, cost-effectiveness, parents’ and staff perspectives. Limitations  As a retrospective population-based observational cohort study it is subject to selection bias in the assignment of location of birth of babies.  Heterogeneity in the quality of care provided within and between LNU and NICU, is likely, and will be addressed.  Formal study-driven neurodevelopmental follow up is not cost-effective in this large cohort, so routinely collected data will be used to investigate their outcomes.