Title: OPTI-Prem: Optimising neonatal service provision for preterm babies born between 27 and 31 weeks of gestation in England using national data, qualitative research and economic analysis
Funder: Department of Health and Social Care

Abstract: Our overarching aim is to improve neonatal service delivery for babies born at 27-31 weeks of gestation in England, by providing evidence-based data for the development of national guidance regarding their optimal place of care. Our research has been endorsed by the British Association of Perinatal Medicine(BAPM), the Royal College of Paediatrics and Child Health, the Neonatal Clinical Reference Group, and UK parent support group and charity for sick and preterm babies(BLISS). The study results will be used to inform and develop recommendations for the delivery of future neonatal health services in England. Three types of units provide neonatal care in England: Neonatal Intensive Care Units(NICUs); Local Neonatal Units(LNUs); and Special Care Baby Units(SCBUs). Babies born at 27-31 weeks of gestation are usually managed in a NICU or LNU. Both have facilities to support babies within this gestational age range. Current practice for this group makes no distinction between care delivered in LNUs and NICUs, as these babies do not all require the highest intensity of care. The decision on where individual babies are born is based on maternal choice at booking, presentation to the nearest hospital and cot capacity at delivery. However, these units differ in terms of facilities, staffing and skill mix for the care of preterm babies, with NICUs providing the very highest level of care. New evidence shows that for babies born at 23-26 weeks, care in a NICU as opposed to a LNU improves survival to discharge; this is shaping their policy. In contrast, there is no evidence to guide location of care for the next most vulnerable group of babies, those born at 27-31 weeks of gestation, whose care is currently spread between 45 NICUs and 84 LNUs. This is an important group to target; they account for 4 times more neonatal unit admissions than those born at 23-26 weeks, and make up 12% of all preterm births in England. They use twice as many neonatal bed days/year in the NHS compared to the group born at 23-26 weeks and over a third of all care days offered to babies in neonatal units. Our primary objective is to assess for preterm babies born at 27-31 weeks and admitted to a neonatal unit, whether care in a NICU compared to a LNU impacts on survival and other key morbidities (up to 1 year), at each gestational age in weeks. Within this we will assess the impact of postnatal transfers between neonatal units (after day 1 of life). Our secondary objectives are to assess (i) whether key differences in clinical care exist between LNUs and NICUs, and if so, whether these are associated with gestation-specific differences in outcomes; (ii) where it is most cost-effective to provide care, (iii) parents’ and clinicians' perspectives on place of care, and how these can be used to guide clinical decision making. This will run over 3 years in 5 work streams: 1.Clinical Outcomes Study: Statistical analysis using routinely collected data from NNRD,HES and ONS for babies born at 27-31 weeks gestation, admitted to neonatal care between 01/01/14-31/12/17 in England, with outcomes up to 1 year of age, 2.Neonatal Unit study exploring differences in care and its impact on outcomes, 3.Economic analysis of care provided in LNUs and NICUs, 4.Ethnographic study exploring parent and clinician perspectives on place of care, 5.Development of recommendations, in collaboration with national bodies, to inform clinical practice, commissioning and policy making

Lay abstract: Things that happen early in a baby’s life are very important for his/her later health and development. Premature babies, born several weeks before their due date, are often very ill in the first weeks and months of life, compared with those born at full term. Because babies’ brains and bodies are still developing at this time, early birth puts them at increased risk of later problems with health and development. It is important that we do everything we can to try to improve the overall health of these children. Not only will this help children and families, but it will also help us understand the correct amount and type of care they will need from the NHS in the future. At present, England has three types of neonatal units: Neonatal Intensive care units (NICUs) that can care for the most sick and most premature babies, Local Neonatal Units (LNUs) that generally care for slightly less sick babies, and Special Care baby units (SCBU) that care for larger premature babies who are generally well, but need time to grow and develop before going home. A recent study suggests that babies born before 26 weeks of pregnancy do better if they are cared for in a NICU. For the next most vulnerable group of premature babies, those born between 27 and 31 weeks of pregnancy, we have no information on whether they benefit from being looked after in one type of unit or another. At present there is no guidance, so these babies may be looked after in either LNUs or NICUs. Babies who are born at this stage of pregnancy cannot be looked after in a SCBU and sometimes need to be moved after birth to either a NICU or LNU. There are 84 LNUs and 45 NICUs in England. In 2014, about half of these babies were cared for in a NICU and half in a LNU. We need to know whether babies born between 27 and 31 weeks are best cared for in a NICU or LNU or if it does not matter. The main things that control where a baby is born are where the mother has her antenatal care, and where there is a cot available for the baby. A mother may have antenatal care in a hospital that has a NICU, LNU or SCBU. Because it is difficult to predict which mother is going to have her baby early, we cannot direct her, at the time of her choosing her hospital for antenatal care, where to go to for care. We cannot be certain before birth which baby is likely to require intensive care, but usually the less mature babies need more intensive care. In this study to find out where it is best to care for babies born at 27-31 weeks of pregnancy, we will look at which type of unit: a) leads to the best outcome for babies born at each week of pregnancy in this range; b) is most cost-effective for families and the NHS and c) best considers views and needs of parents and staff caring for babies. We will use the information we get from the study to help us make recommendations to guide doctors who make decisions about where to look after these babies.We also hope it will help doctors and midwives looking after pregnant women to decide where, if possible and safe for the mother, the baby should be born. We will do this with the help and support of the BAPM and BLISS, the charity for sick and premature babies, and will involve other important agencies. By doing this research and finding out where best to manage babies at each gestational age, we will help to make sure that babies born at 27-31 weeks get the best care in the place that is best able to look after them.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH