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
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
More Related Trials
-
Health-Related Quality-of-Life and Household Financial and Wellbeing Impacts of Prematurity and Necrotising Enterocolitis (NEC).
NCT07192393 ·Status: RECRUITING
-
Prematurity at the Limit of Viability
NCT06391476 ·Status: COMPLETED
-
Cardboard Cot: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib
NCT03344991 ·Status: WITHDRAWN ·Phase: NA
-
Acquisition of Full Oral Feeding and Further Oral Disorders in Extremely Preterm Infants
NCT06648083 ·Status: RECRUITING
-
Systemic Management in Extremely Preterm and Extremely Low Birth Weight Infants
NCT06082414 ·Status: COMPLETED
-
Time to Delivery of Preterm Birth
NCT02853656 ·Status: TERMINATED
-
Predictors for Nasal Intermittent Positive Pressure Ventilation Failure for Premature Infants With Respiratory Distress Syndrome
NCT05260424 ·Status: COMPLETED
-
Effect of Support for Low-Income Mothers of Preterm Infants
NCT06362798 ·Status: RECRUITING ·Phase: NA
-
Preterm Lung Function and Exercise Response Measured by OEP
NCT04239287 ·Status: UNKNOWN
-
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
NCT07161908 ·Status: RECRUITING ·Phase: NA
-
Adolescents Born Preterm; Nurtured Beginnings
NCT00310869 ·Status: UNKNOWN ·Phase: NA
-
Measuring Oxygenation of Newborn Infants in Targeted Oxygen Ranges
NCT03360292 ·Status: COMPLETED ·Phase: NA
-
What is the Impact of Early Life Exposures on the Cardiovascular System in Young Adulthood?
NCT01487824 ·Status: COMPLETED
-
Clinical Grade MIS Device for Cervical Assessment to Predict Preterm Birth
NCT04008485 ·Status: COMPLETED ·Phase: NA
-
Long Term Health Cohort of Premature Infants
NCT05017389 ·Status: RECRUITING
-
Microfluidic Assessment of Clinical Outcomes in Preterm Newborns
NCT03291496 ·Status: ACTIVE_NOT_RECRUITING
-
Observational Study in Preterm Neonates Who Are Sufficiently Stable on Non-Invasive Ventilatory Support
NCT01861795 ·Status: COMPLETED
-
A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants
NCT03298035 ·Status: COMPLETED ·Phase: NA
-
Social Adjustment and Quality of Life After Very Preterm Birth
NCT01163188 ·Status: COMPLETED
-
Initial Oxygen Concentration at Birth in Late-Preterm Infants
NCT07315594 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Interest of Pulmonary Ultrasound to Predict Evolution Towards Bronchopulmonary Dysplasia in Premature Infants at Gestational Age Less Than or Equal to 34 Weeks of Gestation
NCT04209088 ·Status: UNKNOWN ·Phase: NA
-
Children Born Preterm: Sustainable Health Monitoring
NCT06270368 ·Status: RECRUITING
-
CDH - Optimisation of Neonatal Ventilation
NCT02849054 ·Status: UNKNOWN ·Phase: NA
-
Evaluation of Risk Factors Predictive of Hypothermia in Preterm Neonates in Incubators During the First Week of Life
NCT02803606 ·Status: COMPLETED
-
Optimising Breathing Support at Extubation in Very Preterm Infants: A Clinical Study
NCT07251790 ·Status: RECRUITING ·Phase: NA