OPTI-Prem: Optimising Neonatal Service Provision for Preterm Babies Born Between 27 and 31 Weeks of Gestation in England

NCT02994849 | Completed DMC

• 1 other identifier: 2016NEO87
• Study Type: observational
• Target: 4,364
• Locations: 1 country
• Sites: 1

Brief Summary

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 to do everything possible to try to improve the overall health of these children. Not only will this help children and families, but it will also help to 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. 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.

Conditions

Neonatal Diseases and Abnormalities

Outcome Measures

Primary Outcomes (1)

• Survival

  1 year of age

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

preterm babies born at 27-31 weeks

You may qualify if:

• preterm babies born at 27-31 weeks

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead
• University of Leicester: collaborator
• University of Oxford: collaborator
• Neonatal Data Analysis Unit: collaborator
• Imperial College London: collaborator
• Bliss Charity: collaborator

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 32232179 RESULT

• 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.

  PMID: 35760541 RESULT

• 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.

  PMID: 31444186 RESULT

• 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.

  PMID: 39102689 RESULT

• 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.

  PMID: 37130654 RESULT

• 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.

  PMID: 40232009 DERIVED

• 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.

  PMID: 39730195 DERIVED

Related Links

• 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)

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Tilly Pillay

  The Royal Wolverhampton NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 16, 2016
• Study Start: July 19, 2017
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

GB (1)