Condition category
Neonatal Diseases
Date applied
27/02/2017
Date assigned
06/03/2017
Last edited
31/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Things that happen early in a baby’s life are very important for his/her later health and development. 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 that we do everything we can to try to improve the overall health of these children. Not only will this help children and families, but it will also help improve understanding of 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. A recent study suggests that babies born before 26 weeks of pregnancy do better if they are cared for in a NICU. For the next most vulnerable group of premature babies, those born between 27 and 31 weeks of pregnancy, there is no information about whether they would benefit from being looked after in one type of unit or another. The aim of this study is to find out which type of unit leads to the best outcome for babies born at each week of pregnancy in this range is most cost-effective for families and the NHS and best considers views and needs of parents and staff caring for babies.

Who can participate?
Babies born at 27-31 weeks who have been admitted into neonatal units and their parents

What does the study involve?
Babies born between 01/01/2014 and 31/12/2017 are identified using a research database and have information collected about how often they were in hospital during their first year of life is collected. The different types of care offered in LNUs and NICUs to these babies is also reviewed to see if there is a link between the unit they receive care in and their health. The costs of receiving care in the different units are also recorded. Forty parents of premature babies who receive care in these units are also contacted and interviewed to find out their views on the care given to their children. The information collected throughout the study is then used to work out which is the best type of unit to provide care to these children.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.

Where is the study run from?
1. New Cross Hospital (UK)
2. Chelsea and Westminster Hospital (UK)
3. Leicester Royal Infirmary (UK)
4. University of Leicester (UK)

When is the study starting and how long is it expected to run for?
February 2017 to April 2020

Who is funding the study?
Health Services and Delivery Research Programme (UK)

Who is the main contact?
Dr Thillagavathie Pillay
tilly.pillay@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr Thillagavathie Pillay

ORCID ID

http://orcid.org/0000-0002-4159-3282

Contact details

The Royal Wolverhampton NHS Trust
New Cross Hospital
Wolverhampton
WV10 0QP
United Kingdom
+44 (0)1902 695179
tilly.pillay@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT02994849

Protocol/serial number

2016NEO87

Study information

Scientific title

OPTImising neonatal service provision for Preterm babies born between 27 and 31 weeks of gestation using national data, qualitative research and economic analysis

Acronym

OPTI-Prem

Study hypothesis

The aim of this study is to improve neonatal service delivery for babies born between 27 and 31 weeks of gestation in England, by providing evidence-based data for the development of national policy, on the optimal place of care for such babies.

Ethics approval

Tyne and Wear South Ethics Committee, 17/03/2017, REC ref: 17/NE/0080, IRAS ref: 212034

Study design

Multi-centre mixed-methods longitudinal study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Neonatal care

Intervention

This study will be conducted in 5 work streams.

Work stream 1:
Statistical analysis of outcomes based on place of care: Babies born between 01/01/2014 and 31/12/2017 will be identified from the NNRD, The National Neonatal Research Database through NDAU (an independent academic unit based at the Chelsea and Westminster campus of Imperial College in London). This is an established resource for research and service evaluations to improve newborn care. Anonymised data (clinical care and outcomes up to discharge from neonatal unit) on all babies will be extracted. Outcomes (significant hospitalisations and mortality) up to 1 year of age, through linkages to Hospital episode statistics and Office for National Statistics will be studied.

Work stream 2:
This will look at the differences in types of clinical care offered between LNUs and NICUs, and whether this could be statistically linked to differences in outcomes, analysing the results of a clinical questionnaire administered to all LNUs and NICUs in England. A questionnaire on clinical care packages offered in neonatal units will be devised at the start of the project and sent to each neonatal unit for completion. Once these are returned, the results will be anonymised and analysed to see if there are any differences in outcomes that can be linked to specific differences in clinical care packages used between units.

Work stream 3:
This will look at the health economic cost of care for babies at each week of gestational age between 27-31 weeks for those managed in a LNU vs a NICU, using data from Workstream 1.

Work stream 4:
A group of 40 parents who have/have had a preterm baby born between 27-31 weeks gestation, and relevant clinical team members will be selected for interview at two Neonatal units in the collaborators Trusts. A qualitative assessment will be conducted by a social scientist, and research worker, and parents, carers and staff will be approached for informed consent for this. This limb will be conducted over 18 months and appropriate consents will be obtained for this. Parents and staff will be offered information leaflets. Only those consenting to be observed and interviewed will be recruited.

Work stream 5:
This will involve using the results obtained to help develop national recommendations with BAPM, which will be used to inform policy making for where best to deliver and care for preterm babies in this group in the future. All of the results obtained from workstreams 1-4 will be collated and meetings established between the national advisory body for neonatal care (BAPM) and the Study group, overseen by a Parent Panel. This group will work together to define national recommendations on the best place of care for these babies in England. The recommendations that are developed from BAPM will then be sent on to NHS England, to inform policy making for where best to deliver and care for preterm babies in this group in the future.

The total duration of the project is 3 years

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Mortality is assessed through medical record review continuously until children are 1 year old.

Secondary outcome measures

1. Clinical care packages at neonatal units is assessed through clinical questionnaire study created for the purpose of this study at 12 months
2. Cost of care for preterm babies is assessed through health economic calculations for hospitalisation for each baby until the child is 1 year old
3. Parent perspectives of care are assessed using a questionnaire designed for the purpose of this study at baseline and for 18 months

Overall trial start date

27/02/2017

Overall trial end date

01/04/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. All babies born at 27-31 weeks of gestation
2. Admitted into neonatal units
3. Records are captured on the National Neonatal Research Database will be included for the study period between 01/01/2014 and 31/12/2017

Participant type

Mixed

Age group

Neonate

Gender

Both

Target number of participants

24,000

Participant exclusion criteria

Those who elect to opt-out of this project

Recruitment start date

01/04/2017

Recruitment end date

01/04/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

New Cross Hospital
Wednesfield Road
Wolverhampton
WV10 0QP
United Kingdom

Trial participating centre

Chelsea and Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom

Trial participating centre

Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Trial participating centre

University of Leicester
Department of Health Sciences Centre for Medicine University Road
Leicester
LE1 7RH
United Kingdom

Sponsor information

Organisation

The Royal Wolverhampton NHS Trust

Sponsor details

New Cross Hospital
Wolverhampton
WV10 0QP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Health Services and Delivery Research Programme

Alternative name(s)

Health Services and Delivery Research (HS&DR) Programme, NIHR Health Services and Delivery Research (HS&DR) Programme, NIHR Health Services and Delivery Research Programme, HS&DR Programme, HS&DR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in high-impact peer reviewed journals with intent to publish date around one year overall trial end date.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from tilly.pillay@nhs.net and Sarah.glover7@nhs.net

Intention to publish date

01/04/2021

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

31/08/2017: Ethics approval information added.