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

NCT02994849 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4364

Last updated 2025-05-02

No results posted yet for this study

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

Sponsors & Collaborators

  • University of Leicester

    collaborator OTHER
  • University of Oxford

    collaborator OTHER
  • Neonatal Data Analysis Unit

    collaborator UNKNOWN
  • Imperial College London

    collaborator OTHER
  • Bliss Charity

    collaborator OTHER
  • The Royal Wolverhampton Hospitals NHS Trust

    lead OTHER_GOV

Principal Investigators

  • Tilly Pillay · The Royal Wolverhampton NHS Trust

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-19
Primary Completion
2022-08-30
Completion
2022-08-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02994849 on ClinicalTrials.gov