Neonatal Diseases and AbnormalitiesOPTI-PremNCT02994849
OPTI-Prem: Optimising Neonatal Service Provision for Preterm Babies Born Between 27 and 31 Weeks of Gestation in England
An observational study of Neonatal Diseases and Abnormalities, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Neonatal Diseases and Abnormalities
- How many people
- 4,364 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jul 2017to 30 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: preterm babies born at 27-31 weeks
Who may be able to join
- preterm babies born at 27-31 weeks
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Wolverhampton NHS Trust
Wolverhampton, WV10 0QP
About this study
Official 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
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.
Read more
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.
Read the detailed description
Mixed methods, longitudinal study; 5 work streams, supported by a Parent Advisory Panel:
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
- Neonatal Diseases and Abnormalities
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 1 year of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study start19 Jul 2017
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Neonatal Diseases and AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 4,364 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Leicester, University of Oxford, Neonatal Data Analysis Unit, Imperial College London, Bliss Charity
- Responsible party
- Sponsor
- Investigators
- Tilly Pillay, Principal investigator, The Royal Wolverhampton NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994849
- Sponsor's protocol ID
- 2016NEO87
- Acronym
- OPTI-Prem
- Status last verified
- Apr 2025
- First submitted
- 13 Dec 2016
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32232179Cupit 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.
PubMed 35760541Pillay 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.
PubMed 31444186Cupit 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.
PubMed 39102689Yang 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.
PubMed 37130654Pillay 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.
PubMed 40232009Pillay 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.
PubMed 39730195
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02994849
- Acronym / sponsor ID
- OPTI-Prem / 2016NEO87
- Conditions
- Neonatal Diseases and Abnormalities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,364 participants (actual)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Collaborators
- University of Leicester, University of Oxford, Neonatal Data Analysis Unit, Imperial College London, Bliss Charity
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Mixed methods, longitudinal study; 5 work streams, supported by a Parent Advisory Panel:
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- preterm babies born at 27-31 weeks
Key inclusion criteria (1 listed)
- preterm babies born at 27-31 weeks
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival
Time frame: 1 year of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Results publication: PubMed 32232179Ismail 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.
- Results publication: PubMed 35760541Cupit 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.
- Results publication: PubMed 31444186Pillay 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.
- Results publication: PubMed 39102689Cupit 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.
- Results publication: PubMed 37130654Yang 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.
- Derived from this study: PubMed 40232009Pillay 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.
- Derived from this study: PubMed 39730195Pillay 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.
- Clinical outcomes for babies born between 27 - 31 weeks of gestation: Should they be regarded as a single cohort?Link provided by the sponsor.
- Improving outcomes for very preterm babies in England: does place of birth matter? Findings from OPTI-PREM, a national cohort studyLink provided by the sponsor.
- Cost-Effectiveness of Intensive and Local Neonatal Care Units in England: A Real-World Evidence Analysis of a National Birth CohortLink provided by the sponsor.
- Exploring variation in quality of care and clinical outcomes between neonatal units: a novel use for the UK National Neonatal Audit Programme (NNAP)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tilly Pillay principal investigator
The Royal Wolverhampton NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Diseases and Abnormalities, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 1 year of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02994849, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.