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

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ClinicalTrials.gov Identifier: NCT02994849
Recruitment Status : Active, not recruiting
First Posted : December 16, 2016
Last Update Posted : April 22, 2021
Sponsor:
Collaborators:
University of Leicester
University of Oxford
Neonatal Data Analysis Unit
Imperial College London
BLISS charity
Information provided by (Responsible Party):
The Royal Wolverhampton Hospitals NHS Trust

Tracking Information
First Submitted Date December 13, 2016
First Posted Date December 16, 2016
Last Update Posted Date April 22, 2021
Actual Study Start Date July 19, 2017
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 13, 2016)
Survival [ Time Frame: 1 year of age ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title OPTI-Prem: Optimising Neonatal Service Provision for Preterm Babies Born Between 27 and 31 Weeks of Gestation in England
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
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population preterm babies born at 27-31 weeks
Condition Neonatal Diseases and Abnormalities
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: October 29, 2018)
4364
Original Estimated Enrollment
 (submitted: December 13, 2016)
24000
Estimated Study Completion Date September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • preterm babies born at 27-31 weeks

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages up to 1 Year   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02994849
Other Study ID Numbers 2016NEO87
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party The Royal Wolverhampton Hospitals NHS Trust
Study Sponsor The Royal Wolverhampton Hospitals NHS Trust
Collaborators
  • University of Leicester
  • University of Oxford
  • Neonatal Data Analysis Unit
  • Imperial College London
  • BLISS charity
Investigators
Principal Investigator: Tilly Pillay The Royal Wolverhampton NHS Trust
PRS Account The Royal Wolverhampton Hospitals NHS Trust
Verification Date April 2021