TRANSFER

Previous guidance around provision of active care in the most extreme preterm infants (Critical care decisions in fetal and neonatal medicine, Nuffield Council on Bioethics, 2006) meant that active care was very rarely considered for infants 22+0-22+6 weeks’ gestation, and uncommonly for those 23+0-23+6 weeks’ gestation. Improved outcomes for the most extreme preterm infants, reflected in the new guidance, means more infants will be offered active care. Neonatal outcomes are substantially better for extreme preterm infants who are delivered in a maternity setting, which is co-located with a tertiary neonatal intensive care unit (NICU). Therefore, optimal care for those infants on an active care pathway includes the need to ensure antenatal transfer of women with threatened preterm delivery who present in a unit without a NICU. This change means that there will be increased demand for both maternity and neonatal capacity in tertiary settings. Whilst there is national data on the number of infants at these gestations surviving delivery and being admitted to neonatal units, this does not adequately capture the impact on maternity services. The limited and incomplete information regarding the number of women within this gestational age group who need to be transferred to optimise place of birth, results in challenges to service provision and planning. TRANSFER has been designed to answer these important questions.

TRANSFER aims to establish the incidence of women presenting with threatened preterm birth to obstetric units in England, Scotland and Wales and Northern Ireland between 22+0-23+6 weeks’ gestation and determine the number requiring transfer to an obstetric unit with co-located neonatal intensive care unit (NICU) (level 3).  This data is essential to facilitate adequate service provision and planning for obstetric and neonatal units throughout the UK.

TRANSFER is a multi-centre, prospective evaluation of current practice.

All obstetric units within the UK are invited to participate.

There is no change to the patient pathway, as a result of inclusion within TRANSFER.

Ideally, all sites will capture data on all eligible women presenting to their unit within a 13 month time frame.

The project start date is 17-May-21. For 13 months from this date, data on all eligible women (pregnant women ≥16 years old admitted to an obstetric unit with threatened preterm birth between 22+0-23+6 weeks’ gestation), will be recorded.  There is rolling registration for participating centres so sites can start collecting data on consecutive patients after 17-May-21.

All women will be followed up until delivery if before 01-Aug-2022 (the window for including follow up data to the project database will close on 31 July 2022).

Table of the key dates and milestones in the TRANSFER project

Key Dates	Milestone
15-March-2021	Protocol release Site registrations open
17-May-2021	Data collection period starts Participant identification begins
30-June-2022	Participant identification ends
Follow-up period: Follow up to delivery or 31-Jul-2022

• Prospective data collection for a maximum of 13 consecutive months (depending on centre start date)
• Only routinely collected data will be used
• No patient identifiable information will be uploaded to the central project database
• Data will not be published at identifiable hospital level

The project Lead will co-ordinate dissemination of data from this service evaluation. All publications using data from this project to undertake original analyses will be submitted to the SMG for review before release. The success of this project depends on many clinicians. For this reason, credit for the results will not be given to the committees or central organisers, but to all who have collaborated and participated in the project. Acknowledgement will include all collaborators, members of the TRANSFER committees, the SMG and administrative staff. Authorship at the head of the primary results paper will be cited as a collaborative group to avoid giving undue prominence to any individual. All contributors to the trial will be listed at the end of the report, with their contribution to the project identified.

• Prospective data collection for a maximum of 13 consecutive months (depending on centre start date)
• Data will be collected using the secure web application REDCap
• Complete two CRFs for each patient (baseline and outcomes)
• Follow up duration is to delivery

• Register TRANSFER with your hospital audit office

TRANSFER is not considered Research by the NHS (see documents below for HRA decision tool outcome). We advise sites to register TRANSFER as a service evaluation with your Trust. If you have any questions about this please contact us at transfer-study@contacts.bham.ac.uk.

• Sign up a team from your hospital

We have a rolling registration and new centres can still sign up to take part in TRANSFER and start prospective data collection when they have permission from their Trust.

Start putting together a team at your hospital  to help deliver TRANSFER and sign-up using the link https://redcap.link/transferteams. You can do this at the same time as you are applying for approval. You don’t need to wait to have your approvals in place before signing up to take part. We will ask you to nominate a Consultant Lead, and if possible a Trainee Lead. The role of the Consultant Lead is to provide oversight and ensure the regulatory approvals are in place. The Trainee Lead will help to coordinate patient identification and data collection. The information you provide in the survey will help us keep in touch with you during the project and to create logins for you to access the TRANSFER database. 

• Think about the patient pathway

The key to a successful project is identification of all women at risk of delivery between 22+0 - 23+6 weeks' gestation irrespective of whether active care is planned. Please refer to the TRANSFER protocol (see below) and the TRANSFER Project Guide for information on how to establish an effective patient identification pathway at your site.

• TRANSFER opened on 17-May-21

The start date for patient inclusion and data collection was 17-May-21. Your team will be issued with logins to the project database (in REDCap) once local approval is confirmed. The TRANSFER project is designed for data to be uploaded directly to REDCap but hard a copy data collection tool will also be provided to facilitate data collection.