Optimising neonatal services for very preterm births between 27+0 and 31+6 weeks gestation in England: the OPTI-PREM mixed-methods study
Pillay T, Rivero-Arias O, Armstrong N, Seaton SE, Yang M, Banda VL, Dawson K, Ismail AQ, Bountziouka V, Cupit C, Paton A, Manktelow BN, Draper ES, Modi N, Campbell HE, Boyle EM
Record ID 32018014024
English
Authors' objectives:
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
Authors' results and conclusions:
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 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). 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. 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
Authors' methods:
Mixed methods. National Health Service neonatal care, England. 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. Neonatal units in England. 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. 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. 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). 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. 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. Retrospective analysis of resource use data recorded within the NNRD. 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. 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. 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. 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. 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.
Details
Project Status:
Completed
URL for project:
https://www.journalslibrary.nihr.ac.uk/programmes/hsdr/15/70/104
Year Published:
2025
URL for published report:
https://www.journalslibrary.nihr.ac.uk/hsdr/JYWC6538
URL for additional information:
English
English language abstract:
An English language summary is available
Publication Type:
Full HTA
Country:
United Kingdom
DOI:
10.3310/JYWC6538
MeSH Terms
- Infant, Newborn
- Infant, Premature
- Delivery of Health Care
- Delivery of Health Care, Integrated
- Intensive Care Units, Neonatal
- Intensive Care, Neonatal
Contact
Organisation Name:
NIHR Health and Social Care Delivery Program
Contact Name:
Rhiannon Miller
Contact Email:
rhiannon.m@prepress-projects.co.uk
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