OPTI-Prem: Optimising Neonatal Service Provision for Preterm Babies Born Between 27 and 31 Weeks of Gestation in England
NCT ID: NCT02994849
Last Updated: 2025-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
4364 participants
OBSERVATIONAL
2017-07-19
2022-08-30
Brief Summary
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For those premature babies born between 27 and 31 weeks of pregnancy, there is 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. There is the 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, she cannot be directed, at the time of her choosing her hospital for antenatal care, where to go to for care. There is uncertainty 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, the study 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.
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Detailed Description
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Work stream 1:Clinical Outcomes Study Using routinely collected data from the National Neonatal Research Database (NNRD) for babies born at 27-31 weeks of gestation, admitted to neonatal units in England 01/01/14-31/12/17.Estimates of differences in mortality and specified morbidities between babies cared for in LNUs and NICUs will be obtained Data will be linked to Hospital Episode Statistics (morbidity) and ONS(mortality) up to 1 year of age for longer term outcomes.
Work stream 2:Types of clinical care provided Using NNRD, data from a unit questionnaire (01/01/017-31/12/2017), and review of guidelines from neonatal units, variation in clinical practice in 6 areas will be examined: medical/nurse staffing; policies/practice re respiratory support; infection control, feeding and developmental care, discharge and length of stay. Where appropriate, outcomes (mortality, chronic lung disease, central line sepsis, receipt of breastmilk on discharge and length of stay in hospital) by week of gestational age, will be analysed between units with similar practices.
Work stream 3:Economic analysis A cost-effectiveness study comparing costs and outcomes of LNU versus NICU will be conducted.
Work stream 4:Ethnographic study with a representative group of parents and clinicians Observations and interviews will be used to explore factors parents think should guide decision making about place of care and how it happens in practice; clinicians' perspectives/practices on decision making and place of care; impact on parents/families of these decisions and subsequent change in care location; and how parents can best be supported at this time. 40 cases from 2 networks \[20 real-time, 20 retrospective\] will be studied.
Workstream 5:
Once the results of the 4 work streams are analysed, and conclusions reached, a working group will be set up in collaboration with BAPM to develop recommendations to be made available for health service delivery planning.
Conditions
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Study Design
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COHORT
OTHER
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Year
ALL
No
Sponsors
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University of Leicester
OTHER
University of Oxford
OTHER
Neonatal Data Analysis Unit
UNKNOWN
Imperial College London
OTHER
Bliss Charity
OTHER
The Royal Wolverhampton Hospitals NHS Trust
OTHER_GOV
Responsible Party
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Principal Investigators
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Tilly Pillay
Role: PRINCIPAL_INVESTIGATOR
The Royal Wolverhampton NHS Trust
Locations
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The Royal Wolverhampton NHS Trust
Wolverhampton, , United Kingdom
Countries
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References
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Ismail AQT, Boyle EM, Pillay T; OptiPrem Study Group. The impact of level of neonatal care provision on outcomes for preterm babies born between 27 and 31 weeks of gestation, or with a birth weight between 1000 and 1500 g: a review of the literature. BMJ Paediatr Open. 2020 Mar 17;4(1):e000583. doi: 10.1136/bmjpo-2019-000583. eCollection 2020.
Cupit C, Paton A, Boyle E, Pillay T, Armstrong N; OPTI-PREM Study Team. Managerial thinking in neonatal care: a qualitative study of place of care decision-making for preterm babies born at 27-31 weeks gestation in England. BMJ Open. 2022 Jun 27;12(6):e059428. doi: 10.1136/bmjopen-2021-059428.
Pillay T, Modi N, Rivero-Arias O, Manktelow B, Seaton SE, Armstrong N, Draper ES, Dawson K, Paton A, Ismail AQT, Yang M, Boyle EM. 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 Aug 22;9(8):e029421. doi: 10.1136/bmjopen-2019-029421.
Cupit C, Paton A, Boyle E, Pillay T, Anderson J, Armstrong N; OPTI-PREM team. Parenting through place-of-care disruptions: A qualitative study of parents' experiences of neonatal care. Health Expect. 2024 Feb;27(1):e13933. doi: 10.1111/hex.13933.
Yang M, Campbell H, Pillay T, Boyle EM, Modi N, Rivero-Arias O. Neonatal health care costs of very preterm babies in England: a retrospective analysis of a national birth cohort. BMJ Paediatr Open. 2023 May;7(1):e001818. doi: 10.1136/bmjpo-2022-001818.
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. Optimising neonatal services for very preterm births between 27+0 and 31+6 weeks gestation in England: the OPTI-PREM mixed-methods study. Health Soc Care Deliv Res. 2025 Apr;13(12):1-126. doi: 10.3310/JYWC6538.
Pillay T, Seaton SE, Yang M, Bountziouka V, Banda V, Campbell H, Dawson K, Manktelow BN, Draper ES, Modi N, Boyle EM, Rivero-Arias O; OPTI-PREM study group; Contributing neonatal units and leads. Improving outcomes for very preterm babies in England: does place of birth matter? Findings from OPTI-PREM, a national cohort study. Arch Dis Child Fetal Neonatal Ed. 2025 Aug 19;110(5):444-451. doi: 10.1136/archdischild-2024-327474.
Related Links
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Clinical outcomes for babies born between 27 - 31 weeks of gestation: Should they be regarded as a single cohort?
Improving outcomes for very preterm babies in England: does place of birth matter? Findings from OPTI-PREM, a national cohort study
Cost-Effectiveness of Intensive and Local Neonatal Care Units in England: A Real-World Evidence Analysis of a National Birth Cohort
Exploring variation in quality of care and clinical outcomes between neonatal units: a novel use for the UK National Neonatal Audit Programme (NNAP)
Other Identifiers
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2016NEO87
Identifier Type: -
Identifier Source: org_study_id
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