Optimising neonatal services for very preterm births between 27+0 and 31+6 weeks gestation in England: the OPTI-PREM mixed-methods study
Aim To investigate, for preterm babies born between 27+0 and 31+6 weeks gestation in England, optimal place of birth and early care. Design Mixed methods. Setting National Health Service neonatal care, England. Methods To investigate whether birth and early care in neonatal intensive care units (ter...
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| author | Thillagavathie Pillay Oliver Rivero-Arias Natalie Armstrong Sarah E Seaton Miaoqing Yang Victor L Banda Kelvin Dawson Abdul QT Ismail Vasiliki Bountziouka Caroline Cupit Alexis Paton Bradley N Manktelow Elizabeth S Draper Neena Modi Helen E Campbell Elaine M Boyle |
| author_facet | Thillagavathie Pillay Oliver Rivero-Arias Natalie Armstrong Sarah E Seaton Miaoqing Yang Victor L Banda Kelvin Dawson Abdul QT Ismail Vasiliki Bountziouka Caroline Cupit Alexis Paton Bradley N Manktelow Elizabeth S Draper Neena Modi Helen E Campbell Elaine M Boyle |
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| description | Aim To investigate, for preterm babies born between 27+0 and 31+6 weeks gestation in England, optimal place of birth and early care. Design Mixed methods. Setting National Health Service neonatal care, England. Methods To investigate whether birth and early care in neonatal intensive care units (tertiary units) compared to local neonatal units (non-tertiary units) influenced gestation-specific survival and other major outcomes, we analysed data from the National Neonatal Research Database, for 29,842 babies born between 27+0 and 31+6 weeks gestation and discharged from neonatal care between 1 January 2014 and 31 December 2018. We utilised an instrumental variable (maternal excess travel time between local neonatal units and neonatal intensive care units) to control for unmeasured differences. Sensitivity analyses excluded postnatal transfers within 72 hours of birth and multiple births. Outcome measures were death in neonatal care, infant mortality, necrotising enterocolitis, retinopathy of prematurity, severe brain injury, bronchopulmonary dysplasia, and receipt of breast milk at discharge. We also analysed outcomes by volume of neonatal intensive care activity. We undertook a health economic analysis using a cost-effectiveness evaluation from a National Health Service perspective and using additional lives saved as a measure of benefit, explored differences in quality of care in high compared with low-performing units and performed ethnographic qualitative research. Results The safe gestational age cut-off for babies to be born between 27+0 and 31+6 weeks and early care at either location was 28 weeks. We found no effect on mortality in neonatal care (mean difference −0.001; 99% confidence interval −0.011 to 0.010; p = 0.842) or in infancy (mean difference −0.002; 99% confidence interval −0.014 to 0.009; p = 0.579) (n = 18,847), including after sensitivity analyses. A significantly greater proportion of babies in local neonatal units had severe brain injury (mean difference −0.011; 99% confidence interval −0.022 to −0.001; p = 0.007) with the highest mean difference in babies born at 27 weeks (−0.040). Those transferred in the first 72 hours were more likely to have severe brain injury. For 27 weeks gestation, birth in centres with neonatal intensive care units reduced the risk of severe brain injury by 4.2% from 11.9% to 7.7%. The number needed to treat was 25 (99% confidence interval 10 to 59) indicating that 25 babies at 27 weeks would have to be delivered in a neonatal intensive care unit to prevent one severe brain injury. For babies born at 27 weeks gestation, birth in a high-volume unit (> 1600 intensive care days/year) reduced the risk of severe brain injury from 0.242 to 0.028 [99% confidence interval 0.035 to 0.542; p = 0.003; number needed to treat = 4 (99% confidence interval 2 to 29)]. Estimated annual total costs of neonatal care were £262 million. The mean (standard deviation) cost per baby varied from £75,594 (£34,874) at 27 weeks to £27,401 (£14,947) at 31 weeks. Costs were similar between neonatal intensive care units and local neonatal units for births at 27+0 to 29+6 weeks gestation, but higher for local neonatal units for those born at 30+0 to 31+6 weeks. No difference in additional lives saved were observed between the settings. These results suggested that neonatal intensive care units are likely to represent value for money for the National Health Service. However, careful interpretation of this results should be exercised due to the ethical and practical concerns around the reorganisation of neonatal care for very preterm babies from local neonatal units to neonatal intensive care units purely on the grounds of cost savings. We identified a mean reduction in length of stay (1 day; 95% confidence interval 1.029 to 1.081; p < 0.001) in higher-performing units, based on adherence to evidence- and consensus-based measures. Staff reported that decision-making to optimise capacity for babies was an important part of their work. Parents reported valuing their baby’s development, homecoming, continuity of care, inclusion in decision-making, and support for their emotional and physical well-being. Conclusions Birth and early care for babies ≥ 28 weeks is safe in both neonatal intensive care units and local neonatal units in England. For anticipated births at 27 weeks, antenatal transfer of mothers to centres colocated with neonatal intensive care units should be supported. When these inadvertently occur in centres with local neonatal units, clinicians should risk assess decisions for postnatal transfer, taking patient care requirements, staff skills and healthcare resources into consideration and counselling parents regarding the increased risk of severe brain injury associated with transfer. Study registration This study is registered as Current Controlled Trials NCT02994849 and ISRCTN74230187. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 15/70/104) and is published in full in Health and Social Care Delivery Research; Vol. 13, No. 12. See the NIHR Funding and Awards website for further award information.
Plain language summary Preterm babies are at risk of death and serious long-term problems. For babies born at ≤ 26 weeks, we know outcomes are better with birth and care in tertiary maternity and neonatal units. We do not know whether this is true for the next most vulnerable group, born between 27 and 31 weeks. In England, these babies are born and cared for in either neonatal intensive care units (tertiary) or local neonatal units (non-tertiary). We did OPTI-PREM explored whether outcomes for babies born between 27 and 31 weeks differed based on where they were born and cared for. We studied national neonatal data, costs of care, staff and parents’ perspectives, quality of care and outcomes. A parent panel guided us. We found Outcomes were similar for babies born between 28 and 31 weeks. Severe brain injury was identified more in babies born in local neonatal units. A higher proportion was in babies born at 27 weeks and babies who were transferred within 72 hours after birth. To prevent one baby from developing severe brain injury, 25 babies would need to be cared for in neonatal intensive care units as opposed to local neonatal units at 27 weeks gestation. There was no difference in National Health Service neonatal costs for babies born at 27 weeks (~£76,000) between neonatal intensive care units and local neonatal units. £0.26 billion per year was spent on National Health Service neonatal care for babies born between 27 and 31 weeks in England. Staff managed decision-making, to ensure space for babies. Parents valued their baby’s development, homecoming, continuity of care, being included, and having their emotional and physical well-being supported. Our findings suggest babies between 28 and 31 weeks can safely be born and cared for in either local neonatal units or neonatal intensive care units. However, to minimise risk of brain injury, births at 27 weeks should be in maternity units colocated with neonatal intensive care units. Transfers of babies after birth should be avoided where possible.
Scientific summary Background Recent global evidence indicates that place of birth matters for survival and morbidity advantages for extremely preterm babies born at ≤ 26 weeks gestation. This has shaped national policy. We do not know whether this benefit extends to the next most vulnerable group, born between 27+0 and 31+6 weeks gestation (hereafter referred to as born at 27–31 weeks). Globally these may be managed in different types of neonatal facilities. In England, they may be born into maternity units colocated with either neonatal intensive care units (NICU, also known as tertiary neonatal units) or local neonatal units (LNU, also known as non-tertiary neonatal units) and cared for in these. NICU can provide higher intensity of care than LNU, but both have facilities to support babies born at < 32 weeks gestation. Occasionally, they may be born outside these units, but, if viable, are quickly transferred for care in either. Current practice makes no distinction between care in either, as these babies, while vulnerable, do not all require the highest intensity of care. The decision about where an individual babies is born is based on maternal choice at booking, presentation to the nearest hospital and bed/staff capacity at the time of delivery. However, these two types of neonatal unit differ in facilities, staffing and staff skill-mix for care of very preterm babies. Evidence on the most appropriate setting for post-delivery care has been lacking, and questions have been raised around whether, within this cohort of babies born at 27–31 weeks gestation, the optimal care setting could vary across the gestational age range. They account for ~12% of all preterm births and four times the throughput in neonatal units compared to babies born at ≤ 26 weeks gestation. They are a sizeably important group for whom the optimal care setting should be investigated if survival is to be maximised and morbidity minimised. Aim To investigate the best place of birth and early care for preterm babies born at 27–31 weeks gestation in England, so that this evidence can be used to inform and optimise neonatal healthcare delivery in England. Study design Mixed-methods study comprising five workstreams. Setting Neonatal units in England. Workstream 1: A clinical outcomes study: the impact of place of birth and early care on mortality and morbidity in very preterm babies born at 27–31 weeks gestation in England Objective For very preterm babies born at 27–31 weeks gestation in England, and admitted to neonatal units, does birth in maternity units colocated with NICU or LNU offer a survival and/or morbidity advantage? Design National population-based cohort study using quality-assured electronic recorded patient data held within the National Neonatal Research Database (NNRD). For mortality the time horizon was 1 year, and for this, NNRD data were linked with mortality information from NHS Digital, Office for National Statistics. For morbidity, the time horizon was the hospital stay, prior to discharge from neonatal care. Participants Eighteen thousand eight hundred and forty-seven preterm babies born at between 27–31 weeks gestation in maternity units colocated with NICU compared with LNU in England, who were discharged from or died in neonatal care between 1 December 2014 and 31 December 2018. Neonatal care was assigned to unit designation at admission, and early care, to place of care in the first 72 hours of life. Methods We conducted overall and gestation-specific analyses, and adjusted for measured confounders of sex, birthweight z-score, multiplicity, mode of delivery, ethnicity, maternal age and indices of multiple deprivation. We used an instrumental variable approach to control for unmeasured differences between units. The instrument selected was maternal excess travel time between NICU and LNU. We performed sensitivity analyses excluding early postnatal transfers (at 24 hours and up to 72 hours after birth), and multiple births. We also analysed outcomes by volume of neonatal intensive care activity. We studied the outcomes of death in neonatal care, and the first year of life (infant mortality), necrotising enterocolitis (NEC), retinopathy of prematurity (ROP), severe/serious brain injury (SBI), bronchopulmonary dysplasia (BPD), and a care process, the receipt of any breast milk feeds at discharge from neonatal care (BMF). We calculated adjusted mean proportions in each unit with associated mean differences and 99% confidence interval (CI). Results Mortality: We included 18,847 babies (10,379 born into maternity units colocated with NICU and 8468 with LNU). Five hundred and seventy-four babies (3.0%) died while in NICU/LNU care, and a further 121 after discharge from neonatal care, within their first year of life (total infant mortality; 3.7%). There was no effect of place of birth on mortality in neonatal care (mean difference −0.001; p = 0.842) nor infant mortality (mean difference −0.002; p = 0.579). This lack of effect remained after sensitivity analyses. Morbidity: 18,273 babies survived to discharge. The overall rate for NEC was 2.6%, ROP 1.7%, SBI 3.9% and BPD 10%. 55.9% received BMF. We observed an increase in SBI in babies born in maternity units colocated with LNU (mean difference −0.011; p = 0.007). The highest mean difference in gestation-specific SBI was in the group of babies born at 27 weeks gestation (−0.040); those who were transferred in the first 72 hours were more likely to have SBI. Statistical significance was lost after exclusion of early postnatal transfers (n = 1545; mean difference −0.002; p = 0.554) for the whole group, and then separately, on exclusion of all babies born at 27 weeks gestation (mean difference −0.008; p = 0.037). For babies born at 27 weeks gestation, birth in maternity services colocated with NICU reduced the risk of SBI from 11.9% to 7.7%, a reduction of 4.2%. This represented a number needed to treat (NNT) of 25 (99% CI 10 to 59) indicating that 25 babies would need to be delivered in NICU rather than LNU, to prevent one SBI at 27 weeks gestation. For babies born at 27 weeks gestation, birth in a high-volume unit (> 1614 intensive care days/year) reduced the risk of SBI from 0.242 to 0.028 [99% CI 0.035 to 0.542; p = 0.003; NNT = 4 (99% CI 2 to 29)]. There was no effect of place of birth on ROP, NEC or BMF. There was a higher likelihood of BPD in births in maternity units colocated with NICU (mean difference 0.018; p = 0.006). This remained after exclusion of early transfers (mean difference 0.029; p ≤ 0.001) and was lost on exclusion of babies born at 27 weeks gestation (mean difference 0.011; p = 0.065). Conclusions The threshold above which birth and early care can safely be provided close to home, in either NICU or LNU, is 28 weeks gestation. We identified an increased likelihood of SBI in babies born in maternity units colocated with LNU. This appeared to be related to postnatal transfer too. As degree of illness at birth cannot always be predicted for babies born very preterm, our data indicate an urgent need to support antenatal transfers of mothers with expected preterm births at 27 weeks gestation to maternity units colocated with NICU. Where births at 27 weeks gestation inadvertently occur in LNU settings, clinicians should risk assess decisions for transfer. Workstream 2: A clinical quality of care study addressing unit differences (independent of unit designation as neonatal intensive care unit or local neonatal unit) and impact on neonatal outcomes in very preterm babies born at 27–31 weeks gestation in England Objective To investigate the relationship between care provided (irrespective of unit designation) and outcomes for very preterm babies born at 27–31 weeks gestation. Methods We identified two areas to explore quality of neonatal care: (a) adherence to prespecified targets or benchmarks for clinical care measures, defined within the National Neonatal Audit Programme (NNAP), and data completion for these on the electronic patient records, and (b) benchmarking in the upper quartile for additional early preterm care evidence-based measures that could be extracted from our OPTI-PREM data set. We categorised units as high performing for quality of care based on their meeting of prespecified targets set by the NNAP for different measures, and for being above the upper quartile for benchmarking exercises. We developed a hierarchical list and compared those units above the top quartile (high-performing units) with those below the upper quartile (lower-performing units). We compared the demographic profiles and unit characteristics and conducted multivariate analyses (linear and logistic regression) exploring associations with length of stay and pre-discharge mortality. Results We identified a mean reduction in length of stay of 1 day for babies born at 27–31 weeks gestation in units within the top quartile, for high-performing units (95% CI 1.029 to 1.081; p < 0.001). We did not find a significant difference in pre-discharge mortality. Units in high areas of social deprivation and those with fewer staff were less likely to be higher-performing units. Limitations Our sample size was restricted to 1 year of the OPTI-PREM cohort, to limit the effect of unit change in care processes and structure on quality of care delivered. Conclusions If duration of hospital stay is influenced by the quality of care provided in units, our observations have patient-flow and cost-saving implications for neonatal units and the NHS. Workstream 3: (a) Cost of neonatal care provided for very preterm babies born at 27–31 weeks gestation in neonatal intensive care unit and local neonatal unit in England within the National Health Service setting Objective To estimate neonatal costs to hospital discharge for very preterm babies born at 27–31 weeks gestation in NICU and LNU. Design Retrospective analysis of resource use data recorded within the NNRD. Patients Babies born at 27–31 weeks gestation in England and discharged from a neonatal unit between 1 April 2014 and 31 December 2018. Main outcome measures We costed days receiving different levels of neonatal care, along with other specialised clinical activities. We present mean resource use and costs per baby by gestational age at birth, along with total costs for the cohort. Results We used data for 28,154 very preterm babies born at 27–31 weeks gestation and estimated the annual total costs of neonatal care to be £262 million. 95% of costs were attributable to routine daily care provided by units. The mean (standard deviation) cost per baby of daily care varied by gestational age at birth; £75,594 (£34,874) at 27 weeks as compared with £27,401 (£14,947) at 31 weeks. Conclusions The findings presented here are a useful resource to stakeholders including NHS managers, clinicians, researchers and policy-makers. Workstream 3: (b) A cost-effectiveness analysis: comparing the costs and effects of care for very preterm babies born at 27–31 weeks gestation in neonatal intensive care unit compared with local neonatal unit in England within the National Health Service setting Objective We quantified and compared the costs and effects of care provided to preterm babies born at 27–31 weeks gestation in NICU compared with LNU in England. Methods We analysed data from theNNRD for very preterm babies born at 27–31 weeks gestation, admitted to neonatal units in England and discharged between 1 January 2014 and 31 December 2018. We costed data on the daily levels of neonatal care provided to each baby and on key healthcare interventions, using unit costs from established sources. Survival status at neonatal unit discharge was our measure of health outcome. To facilitate an unbiased comparison of NICU and LNU, we adjusted for measured confounders and used an instrumental variable approach to account for unmeasured confounders. Results We did not observe a difference in mortality between babies admitted to NICU compared with LNU. The mean cost of babies managed in NICU (£45,860 SE = £313) was lower than the cost of babies managed in LNU (£48,393, SE = £386) [mean cost difference −£2534 (99% CI −£4096 to −£971)]. The costs of care for babies born at 27–29 weeks gestation were not significantly different between NICU and LNU. Costs were only significantly lower for babies born in NICU at later gestations (30 and 31 weeks) and were driven by differences in the durations of different levels of care provided. Conclusions Redirecting care of less sick very preterm babies to NICU to reduce costs may be challenging. Instead, research is needed to understand the reasons for the differences in the durations of intensive care between settings. Workstream 4: A qualitative ethnographic study exploring place of care decision-making and the perspectives of parents and clinicians, for very preterm babies born at 27–31 weeks gestation in neonatal intensive care unit and local neonatal unit in England Objective To assess staff and parent perspectives on place of care for very preterm births at 27–31 weeks gestation in England. Design We undertook qualitative studies using an ethnographic approach that included observations of routine behaviours in their natural settings (‘work-as-done’ rather than ‘work-as-imagined’) and interviews with staff and parents. Participants Parents of babies born at 27–31 weeks gestation from across all geographic areas in England (retrospective and contemporaneous); staff working in four LNU and two NICU, in two neonatal operational delivery networks, and in neonatal transport teams. Results Staff were dealing with multiple priorities, making decisions in a rapidly evolving, time-consuming, unstandardised way. The complexities of decision-making and enacting place of care decisions, contextualising decisions and integrating managerial thinking into their decision-making processes was evident. For parents, being able to care for their baby while on the neonatal unit was a priority. Transfer of a baby disrupted parental care and parenthood. It carried with it multiple stresses, including getting to know and to trust the new unit, and the impact of being far from home. Access to practical and emotional support was limited for parents. Optimising their baby’s development and preparing for homecoming were important to parents. Conclusions Place of care discussions should include assessment of the burden placed on staff, and parents of various socioeconomic backgrounds, and the consequent ability to maintain continuity of care in the face of disruptions. Discussions and reviews of how resources are employed in neonatal units are required to optimise efficiency of staff working, and improve experiences of neonatal care for babies, parents and families. Workstream 5: Stakeholder engagements on OPTI-PREM findings Objective To engage with stakeholders regarding investigation, findings and implications of findings from OPTI-PREM. Design We held multiple meetings with stakeholders from national bodies, regional networks and individual units. These were individuals involved in decision-making for delivery of NHS neonatal service provision of neonatal and obstetric clinical care, managers, operational delivery network leads, researchers, parents and members of the public. We presented at neonatal and obstetric meetings to discuss the project, results, and to obtain peer review in the form of comments and constructive criticism from these presentations. Results Scientific evidence was shared and considered timely, highly relevant and robust. Key stakeholders engaged, supported the OPTI-PREM project, and participated in discussions on potential implications of our findings. Ideas, critiques and suggestions have been considered and actioned where appropriate within this report. This engagement is ongoing. Conclusions OPTI-PREM findings provide timely, important scientific evidence for policy-makers and stakeholders to utilise, in optimising neonatal health care for very preterm babies born at 27–31 weeks gestation. Our findings align with the NHS 2023 3-year delivery plan for maternity and neonatal services in England. Study registration This study is registered as Current Controlled Trials NCT02994849 and ISRCTN74230187. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 15/70/104) and is published in full in Health and Social Care Delivery Research; Vol. 13, No. 12. See the NIHR Funding and Awards website for further award information. |
| format | Article |
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| institution | OA Journals |
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| spelling | doaj-art-33d964441e394ec495d9d992eb2eb68f2025-08-20T02:26:28ZengNIHR Journals LibraryHealth and Social Care Delivery Research2755-00792025-04-01131210.3310/JYWC653815/70/104Optimising neonatal services for very preterm births between 27+0 and 31+6 weeks gestation in England: the OPTI-PREM mixed-methods studyThillagavathie Pillay0Oliver Rivero-Arias1Natalie Armstrong2Sarah E Seaton3Miaoqing Yang4Victor L Banda5Kelvin Dawson6Abdul QT Ismail7Vasiliki Bountziouka8Caroline Cupit9Alexis Paton10Bradley N Manktelow11Elizabeth S Draper12Neena Modi13Helen E Campbell14Elaine M Boyle15Faculty of Science and Engineering, University of Wolverhampton, Wolverhampton, UKNational Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UKDepartment of Population Health Sciences, University of Leicester, Leicester, UKDepartment of Population Health Sciences, University of Leicester, Leicester, UKNational Institute for Health and Care Excellence, London, UKData Research, Innovation and Virtual Environment, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UKBLISS, London, UKDepartment of Population Health Sciences, University of Leicester, Leicester, UKDepartment of Population Health Sciences, University of Leicester, Leicester, UKDepartment of Population Health Sciences, University of Leicester, Leicester, UKSchool of Social Sciences and Humanities, College of Business and Social Science, University of Aston, Birmingham, UKDepartment of Population Health Sciences, University of Leicester, Leicester, UKDepartment of Population Health Sciences, University of Leicester, Leicester, UKSchool of Public Health, Chelsea and Westminster Hospital Campus, Imperial College London, London, UKNational Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UKDepartment of Population Health Sciences, University of Leicester, Leicester, UKAim To investigate, for preterm babies born between 27+0 and 31+6 weeks gestation in England, optimal place of birth and early care. Design Mixed methods. Setting National Health Service neonatal care, England. Methods To investigate whether birth and early care in neonatal intensive care units (tertiary units) compared to local neonatal units (non-tertiary units) influenced gestation-specific survival and other major outcomes, we analysed data from the National Neonatal Research Database, for 29,842 babies born between 27+0 and 31+6 weeks gestation and discharged from neonatal care between 1 January 2014 and 31 December 2018. We utilised an instrumental variable (maternal excess travel time between local neonatal units and neonatal intensive care units) to control for unmeasured differences. Sensitivity analyses excluded postnatal transfers within 72 hours of birth and multiple births. Outcome measures were death in neonatal care, infant mortality, necrotising enterocolitis, retinopathy of prematurity, severe brain injury, bronchopulmonary dysplasia, and receipt of breast milk at discharge. We also analysed outcomes by volume of neonatal intensive care activity. We undertook a health economic analysis using a cost-effectiveness evaluation from a National Health Service perspective and using additional lives saved as a measure of benefit, explored differences in quality of care in high compared with low-performing units and performed ethnographic qualitative research. Results The safe gestational age cut-off for babies to be born between 27+0 and 31+6 weeks and early care at either location was 28 weeks. We found no effect on mortality in neonatal care (mean difference −0.001; 99% confidence interval −0.011 to 0.010; p = 0.842) or in infancy (mean difference −0.002; 99% confidence interval −0.014 to 0.009; p = 0.579) (n = 18,847), including after sensitivity analyses. A significantly greater proportion of babies in local neonatal units had severe brain injury (mean difference −0.011; 99% confidence interval −0.022 to −0.001; p = 0.007) with the highest mean difference in babies born at 27 weeks (−0.040). Those transferred in the first 72 hours were more likely to have severe brain injury. For 27 weeks gestation, birth in centres with neonatal intensive care units reduced the risk of severe brain injury by 4.2% from 11.9% to 7.7%. The number needed to treat was 25 (99% confidence interval 10 to 59) indicating that 25 babies at 27 weeks would have to be delivered in a neonatal intensive care unit to prevent one severe brain injury. For babies born at 27 weeks gestation, birth in a high-volume unit (> 1600 intensive care days/year) reduced the risk of severe brain injury from 0.242 to 0.028 [99% confidence interval 0.035 to 0.542; p = 0.003; number needed to treat = 4 (99% confidence interval 2 to 29)]. Estimated annual total costs of neonatal care were £262 million. The mean (standard deviation) cost per baby varied from £75,594 (£34,874) at 27 weeks to £27,401 (£14,947) at 31 weeks. Costs were similar between neonatal intensive care units and local neonatal units for births at 27+0 to 29+6 weeks gestation, but higher for local neonatal units for those born at 30+0 to 31+6 weeks. No difference in additional lives saved were observed between the settings. These results suggested that neonatal intensive care units are likely to represent value for money for the National Health Service. However, careful interpretation of this results should be exercised due to the ethical and practical concerns around the reorganisation of neonatal care for very preterm babies from local neonatal units to neonatal intensive care units purely on the grounds of cost savings. We identified a mean reduction in length of stay (1 day; 95% confidence interval 1.029 to 1.081; p < 0.001) in higher-performing units, based on adherence to evidence- and consensus-based measures. Staff reported that decision-making to optimise capacity for babies was an important part of their work. Parents reported valuing their baby’s development, homecoming, continuity of care, inclusion in decision-making, and support for their emotional and physical well-being. Conclusions Birth and early care for babies ≥ 28 weeks is safe in both neonatal intensive care units and local neonatal units in England. For anticipated births at 27 weeks, antenatal transfer of mothers to centres colocated with neonatal intensive care units should be supported. When these inadvertently occur in centres with local neonatal units, clinicians should risk assess decisions for postnatal transfer, taking patient care requirements, staff skills and healthcare resources into consideration and counselling parents regarding the increased risk of severe brain injury associated with transfer. Study registration This study is registered as Current Controlled Trials NCT02994849 and ISRCTN74230187. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 15/70/104) and is published in full in Health and Social Care Delivery Research; Vol. 13, No. 12. See the NIHR Funding and Awards website for further award information. Plain language summary Preterm babies are at risk of death and serious long-term problems. For babies born at ≤ 26 weeks, we know outcomes are better with birth and care in tertiary maternity and neonatal units. We do not know whether this is true for the next most vulnerable group, born between 27 and 31 weeks. In England, these babies are born and cared for in either neonatal intensive care units (tertiary) or local neonatal units (non-tertiary). We did OPTI-PREM explored whether outcomes for babies born between 27 and 31 weeks differed based on where they were born and cared for. We studied national neonatal data, costs of care, staff and parents’ perspectives, quality of care and outcomes. A parent panel guided us. We found Outcomes were similar for babies born between 28 and 31 weeks. Severe brain injury was identified more in babies born in local neonatal units. A higher proportion was in babies born at 27 weeks and babies who were transferred within 72 hours after birth. To prevent one baby from developing severe brain injury, 25 babies would need to be cared for in neonatal intensive care units as opposed to local neonatal units at 27 weeks gestation. There was no difference in National Health Service neonatal costs for babies born at 27 weeks (~£76,000) between neonatal intensive care units and local neonatal units. £0.26 billion per year was spent on National Health Service neonatal care for babies born between 27 and 31 weeks in England. Staff managed decision-making, to ensure space for babies. Parents valued their baby’s development, homecoming, continuity of care, being included, and having their emotional and physical well-being supported. Our findings suggest babies between 28 and 31 weeks can safely be born and cared for in either local neonatal units or neonatal intensive care units. However, to minimise risk of brain injury, births at 27 weeks should be in maternity units colocated with neonatal intensive care units. Transfers of babies after birth should be avoided where possible. Scientific summary Background Recent global evidence indicates that place of birth matters for survival and morbidity advantages for extremely preterm babies born at ≤ 26 weeks gestation. This has shaped national policy. We do not know whether this benefit extends to the next most vulnerable group, born between 27+0 and 31+6 weeks gestation (hereafter referred to as born at 27–31 weeks). Globally these may be managed in different types of neonatal facilities. In England, they may be born into maternity units colocated with either neonatal intensive care units (NICU, also known as tertiary neonatal units) or local neonatal units (LNU, also known as non-tertiary neonatal units) and cared for in these. NICU can provide higher intensity of care than LNU, but both have facilities to support babies born at < 32 weeks gestation. Occasionally, they may be born outside these units, but, if viable, are quickly transferred for care in either. Current practice makes no distinction between care in either, as these babies, while vulnerable, do not all require the highest intensity of care. The decision about where an individual babies is born is based on maternal choice at booking, presentation to the nearest hospital and bed/staff capacity at the time of delivery. However, these two types of neonatal unit differ in facilities, staffing and staff skill-mix for care of very preterm babies. Evidence on the most appropriate setting for post-delivery care has been lacking, and questions have been raised around whether, within this cohort of babies born at 27–31 weeks gestation, the optimal care setting could vary across the gestational age range. They account for ~12% of all preterm births and four times the throughput in neonatal units compared to babies born at ≤ 26 weeks gestation. They are a sizeably important group for whom the optimal care setting should be investigated if survival is to be maximised and morbidity minimised. Aim To investigate the best place of birth and early care for preterm babies born at 27–31 weeks gestation in England, so that this evidence can be used to inform and optimise neonatal healthcare delivery in England. Study design Mixed-methods study comprising five workstreams. Setting Neonatal units in England. Workstream 1: A clinical outcomes study: the impact of place of birth and early care on mortality and morbidity in very preterm babies born at 27–31 weeks gestation in England Objective For very preterm babies born at 27–31 weeks gestation in England, and admitted to neonatal units, does birth in maternity units colocated with NICU or LNU offer a survival and/or morbidity advantage? Design National population-based cohort study using quality-assured electronic recorded patient data held within the National Neonatal Research Database (NNRD). For mortality the time horizon was 1 year, and for this, NNRD data were linked with mortality information from NHS Digital, Office for National Statistics. For morbidity, the time horizon was the hospital stay, prior to discharge from neonatal care. Participants Eighteen thousand eight hundred and forty-seven preterm babies born at between 27–31 weeks gestation in maternity units colocated with NICU compared with LNU in England, who were discharged from or died in neonatal care between 1 December 2014 and 31 December 2018. Neonatal care was assigned to unit designation at admission, and early care, to place of care in the first 72 hours of life. Methods We conducted overall and gestation-specific analyses, and adjusted for measured confounders of sex, birthweight z-score, multiplicity, mode of delivery, ethnicity, maternal age and indices of multiple deprivation. We used an instrumental variable approach to control for unmeasured differences between units. The instrument selected was maternal excess travel time between NICU and LNU. We performed sensitivity analyses excluding early postnatal transfers (at 24 hours and up to 72 hours after birth), and multiple births. We also analysed outcomes by volume of neonatal intensive care activity. We studied the outcomes of death in neonatal care, and the first year of life (infant mortality), necrotising enterocolitis (NEC), retinopathy of prematurity (ROP), severe/serious brain injury (SBI), bronchopulmonary dysplasia (BPD), and a care process, the receipt of any breast milk feeds at discharge from neonatal care (BMF). We calculated adjusted mean proportions in each unit with associated mean differences and 99% confidence interval (CI). Results Mortality: We included 18,847 babies (10,379 born into maternity units colocated with NICU and 8468 with LNU). Five hundred and seventy-four babies (3.0%) died while in NICU/LNU care, and a further 121 after discharge from neonatal care, within their first year of life (total infant mortality; 3.7%). There was no effect of place of birth on mortality in neonatal care (mean difference −0.001; p = 0.842) nor infant mortality (mean difference −0.002; p = 0.579). This lack of effect remained after sensitivity analyses. Morbidity: 18,273 babies survived to discharge. The overall rate for NEC was 2.6%, ROP 1.7%, SBI 3.9% and BPD 10%. 55.9% received BMF. We observed an increase in SBI in babies born in maternity units colocated with LNU (mean difference −0.011; p = 0.007). The highest mean difference in gestation-specific SBI was in the group of babies born at 27 weeks gestation (−0.040); those who were transferred in the first 72 hours were more likely to have SBI. Statistical significance was lost after exclusion of early postnatal transfers (n = 1545; mean difference −0.002; p = 0.554) for the whole group, and then separately, on exclusion of all babies born at 27 weeks gestation (mean difference −0.008; p = 0.037). For babies born at 27 weeks gestation, birth in maternity services colocated with NICU reduced the risk of SBI from 11.9% to 7.7%, a reduction of 4.2%. This represented a number needed to treat (NNT) of 25 (99% CI 10 to 59) indicating that 25 babies would need to be delivered in NICU rather than LNU, to prevent one SBI at 27 weeks gestation. For babies born at 27 weeks gestation, birth in a high-volume unit (> 1614 intensive care days/year) reduced the risk of SBI from 0.242 to 0.028 [99% CI 0.035 to 0.542; p = 0.003; NNT = 4 (99% CI 2 to 29)]. There was no effect of place of birth on ROP, NEC or BMF. There was a higher likelihood of BPD in births in maternity units colocated with NICU (mean difference 0.018; p = 0.006). This remained after exclusion of early transfers (mean difference 0.029; p ≤ 0.001) and was lost on exclusion of babies born at 27 weeks gestation (mean difference 0.011; p = 0.065). Conclusions The threshold above which birth and early care can safely be provided close to home, in either NICU or LNU, is 28 weeks gestation. We identified an increased likelihood of SBI in babies born in maternity units colocated with LNU. This appeared to be related to postnatal transfer too. As degree of illness at birth cannot always be predicted for babies born very preterm, our data indicate an urgent need to support antenatal transfers of mothers with expected preterm births at 27 weeks gestation to maternity units colocated with NICU. Where births at 27 weeks gestation inadvertently occur in LNU settings, clinicians should risk assess decisions for transfer. Workstream 2: A clinical quality of care study addressing unit differences (independent of unit designation as neonatal intensive care unit or local neonatal unit) and impact on neonatal outcomes in very preterm babies born at 27–31 weeks gestation in England Objective To investigate the relationship between care provided (irrespective of unit designation) and outcomes for very preterm babies born at 27–31 weeks gestation. Methods We identified two areas to explore quality of neonatal care: (a) adherence to prespecified targets or benchmarks for clinical care measures, defined within the National Neonatal Audit Programme (NNAP), and data completion for these on the electronic patient records, and (b) benchmarking in the upper quartile for additional early preterm care evidence-based measures that could be extracted from our OPTI-PREM data set. We categorised units as high performing for quality of care based on their meeting of prespecified targets set by the NNAP for different measures, and for being above the upper quartile for benchmarking exercises. We developed a hierarchical list and compared those units above the top quartile (high-performing units) with those below the upper quartile (lower-performing units). We compared the demographic profiles and unit characteristics and conducted multivariate analyses (linear and logistic regression) exploring associations with length of stay and pre-discharge mortality. Results We identified a mean reduction in length of stay of 1 day for babies born at 27–31 weeks gestation in units within the top quartile, for high-performing units (95% CI 1.029 to 1.081; p < 0.001). We did not find a significant difference in pre-discharge mortality. Units in high areas of social deprivation and those with fewer staff were less likely to be higher-performing units. Limitations Our sample size was restricted to 1 year of the OPTI-PREM cohort, to limit the effect of unit change in care processes and structure on quality of care delivered. Conclusions If duration of hospital stay is influenced by the quality of care provided in units, our observations have patient-flow and cost-saving implications for neonatal units and the NHS. Workstream 3: (a) Cost of neonatal care provided for very preterm babies born at 27–31 weeks gestation in neonatal intensive care unit and local neonatal unit in England within the National Health Service setting Objective To estimate neonatal costs to hospital discharge for very preterm babies born at 27–31 weeks gestation in NICU and LNU. Design Retrospective analysis of resource use data recorded within the NNRD. Patients Babies born at 27–31 weeks gestation in England and discharged from a neonatal unit between 1 April 2014 and 31 December 2018. Main outcome measures We costed days receiving different levels of neonatal care, along with other specialised clinical activities. We present mean resource use and costs per baby by gestational age at birth, along with total costs for the cohort. Results We used data for 28,154 very preterm babies born at 27–31 weeks gestation and estimated the annual total costs of neonatal care to be £262 million. 95% of costs were attributable to routine daily care provided by units. The mean (standard deviation) cost per baby of daily care varied by gestational age at birth; £75,594 (£34,874) at 27 weeks as compared with £27,401 (£14,947) at 31 weeks. Conclusions The findings presented here are a useful resource to stakeholders including NHS managers, clinicians, researchers and policy-makers. Workstream 3: (b) A cost-effectiveness analysis: comparing the costs and effects of care for very preterm babies born at 27–31 weeks gestation in neonatal intensive care unit compared with local neonatal unit in England within the National Health Service setting Objective We quantified and compared the costs and effects of care provided to preterm babies born at 27–31 weeks gestation in NICU compared with LNU in England. Methods We analysed data from theNNRD for very preterm babies born at 27–31 weeks gestation, admitted to neonatal units in England and discharged between 1 January 2014 and 31 December 2018. We costed data on the daily levels of neonatal care provided to each baby and on key healthcare interventions, using unit costs from established sources. Survival status at neonatal unit discharge was our measure of health outcome. To facilitate an unbiased comparison of NICU and LNU, we adjusted for measured confounders and used an instrumental variable approach to account for unmeasured confounders. Results We did not observe a difference in mortality between babies admitted to NICU compared with LNU. The mean cost of babies managed in NICU (£45,860 SE = £313) was lower than the cost of babies managed in LNU (£48,393, SE = £386) [mean cost difference −£2534 (99% CI −£4096 to −£971)]. The costs of care for babies born at 27–29 weeks gestation were not significantly different between NICU and LNU. Costs were only significantly lower for babies born in NICU at later gestations (30 and 31 weeks) and were driven by differences in the durations of different levels of care provided. Conclusions Redirecting care of less sick very preterm babies to NICU to reduce costs may be challenging. Instead, research is needed to understand the reasons for the differences in the durations of intensive care between settings. Workstream 4: A qualitative ethnographic study exploring place of care decision-making and the perspectives of parents and clinicians, for very preterm babies born at 27–31 weeks gestation in neonatal intensive care unit and local neonatal unit in England Objective To assess staff and parent perspectives on place of care for very preterm births at 27–31 weeks gestation in England. Design We undertook qualitative studies using an ethnographic approach that included observations of routine behaviours in their natural settings (‘work-as-done’ rather than ‘work-as-imagined’) and interviews with staff and parents. Participants Parents of babies born at 27–31 weeks gestation from across all geographic areas in England (retrospective and contemporaneous); staff working in four LNU and two NICU, in two neonatal operational delivery networks, and in neonatal transport teams. Results Staff were dealing with multiple priorities, making decisions in a rapidly evolving, time-consuming, unstandardised way. The complexities of decision-making and enacting place of care decisions, contextualising decisions and integrating managerial thinking into their decision-making processes was evident. For parents, being able to care for their baby while on the neonatal unit was a priority. Transfer of a baby disrupted parental care and parenthood. It carried with it multiple stresses, including getting to know and to trust the new unit, and the impact of being far from home. Access to practical and emotional support was limited for parents. Optimising their baby’s development and preparing for homecoming were important to parents. Conclusions Place of care discussions should include assessment of the burden placed on staff, and parents of various socioeconomic backgrounds, and the consequent ability to maintain continuity of care in the face of disruptions. Discussions and reviews of how resources are employed in neonatal units are required to optimise efficiency of staff working, and improve experiences of neonatal care for babies, parents and families. Workstream 5: Stakeholder engagements on OPTI-PREM findings Objective To engage with stakeholders regarding investigation, findings and implications of findings from OPTI-PREM. Design We held multiple meetings with stakeholders from national bodies, regional networks and individual units. These were individuals involved in decision-making for delivery of NHS neonatal service provision of neonatal and obstetric clinical care, managers, operational delivery network leads, researchers, parents and members of the public. We presented at neonatal and obstetric meetings to discuss the project, results, and to obtain peer review in the form of comments and constructive criticism from these presentations. Results Scientific evidence was shared and considered timely, highly relevant and robust. Key stakeholders engaged, supported the OPTI-PREM project, and participated in discussions on potential implications of our findings. Ideas, critiques and suggestions have been considered and actioned where appropriate within this report. This engagement is ongoing. Conclusions OPTI-PREM findings provide timely, important scientific evidence for policy-makers and stakeholders to utilise, in optimising neonatal health care for very preterm babies born at 27–31 weeks gestation. Our findings align with the NHS 2023 3-year delivery plan for maternity and neonatal services in England. Study registration This study is registered as Current Controlled Trials NCT02994849 and ISRCTN74230187. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 15/70/104) and is published in full in Health and Social Care Delivery Research; Vol. 13, No. 12. See the NIHR Funding and Awards website for further award information.https://doi.org/10.3310/JYWC6538pretermgestationnicuneonatalbrainretinopathy of prematuritybronchopulmonary dysplasianecrotising enterocolitisbreast milkeconomic evaluationobservational study |
| spellingShingle | Thillagavathie Pillay Oliver Rivero-Arias Natalie Armstrong Sarah E Seaton Miaoqing Yang Victor L Banda Kelvin Dawson Abdul QT Ismail Vasiliki Bountziouka Caroline Cupit Alexis Paton Bradley N Manktelow Elizabeth S Draper Neena Modi Helen E Campbell Elaine M Boyle Optimising neonatal services for very preterm births between 27+0 and 31+6 weeks gestation in England: the OPTI-PREM mixed-methods study Health and Social Care Delivery Research preterm gestation nicu neonatal brain retinopathy of prematurity bronchopulmonary dysplasia necrotising enterocolitis breast milk economic evaluation observational study |
| title | Optimising neonatal services for very preterm births between 27+0 and 31+6 weeks gestation in England: the OPTI-PREM mixed-methods study |
| title_full | Optimising neonatal services for very preterm births between 27+0 and 31+6 weeks gestation in England: the OPTI-PREM mixed-methods study |
| title_fullStr | Optimising neonatal services for very preterm births between 27+0 and 31+6 weeks gestation in England: the OPTI-PREM mixed-methods study |
| title_full_unstemmed | Optimising neonatal services for very preterm births between 27+0 and 31+6 weeks gestation in England: the OPTI-PREM mixed-methods study |
| title_short | Optimising neonatal services for very preterm births between 27+0 and 31+6 weeks gestation in England: the OPTI-PREM mixed-methods study |
| title_sort | optimising neonatal services for very preterm births between 27 0 and 31 6 weeks gestation in england the opti prem mixed methods study |
| topic | preterm gestation nicu neonatal brain retinopathy of prematurity bronchopulmonary dysplasia necrotising enterocolitis breast milk economic evaluation observational study |
| url | https://doi.org/10.3310/JYWC6538 |
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