Continuing Care Sites
What are Continuing Care Site (CCS)
Continuing Care Site (CCS) – the hospital where a baby recruited on a neonatal trial is transferred to, for continuation of their clinical care. A CCS is responsible for continuing the intervention and completion of data collection forms.
Key information to know about neoGASTRIC:
- We are comparing two ways of caring for babies having tube feeds, both ways are part of routine care and both are commonly used in neonatal units across the UK and Australia
- We do not believe there are any additional risks in taking part
- We will collect information about babies and their feeds
- All eligible babies will be included the study unless parents/carers wish to opt-out
- This study is being run in more than 30 hospitals in the UK and Australia
- The trial will run for about 4 years
About Us
NeoGASTRIC is coordinated by the National Perinatal Epidemiology Unit, Clinical Trials Unit (NPEU CTU) at the University of Oxford, England, UK, in partnership with Monash University, Australia. The study is funded by the National Institute for Health and Care Research (NIHR) in the UK and the National Health and Medical Research Council (NHMRC) in Australia.
Please refer to the sections below for more information and resources.
Training Slides
Welcome to our training slides section. Below, you will find a collection of slides designed to support your role. These slides provide detailed information about the trial and best practices.
Guidance Sheets
- neoGASTRIC Guidance Sheet 1 Trial one-page summary v1.0 02062023
- neoGASTRIC Guidance Sheet 5 Daily feed log FAQs v1.0 31.05.2023
- neoGASTRIC Guidance Sheet 6a Transfer of Infants v1.0 31.05.2023
- neoGASTRIC Guidance Sheet 8 SAE and Incident reporting UK Version v1.0 31.05.2023
- neoGASTRIC Guidance Sheet 9 Emergency queries v1.0 31.05.2023
- neoGASTRIC Guidance Sheet 11 For Continuing Care Sites v1.0 31.05.2023
Resources
- Late Onset Infections and Gut Signs Form
- Hospital Transfer Discharge Form UK
- Daily Feed Log (Days 1 - 14)
- Daily Feed Log (Day 15 onwards)
- SAE Report Form
- Incident and Deviation Form
Frequently Asked Questions (FAQs)
What is a Continuing Care Site (CCS)?
A continuing care site (CCS) is a site where an infant is transferred to from a named neoGASTRIC recruiting site. A CCS will receive a Transfer Pack with information about the neoGASTRIC trial including any instructions on the data collection process that is required in order to continue the infant's participation in the trial.
All registered Continuing Care Sites are listed in orange on the neoGASTRIC website under the "Sites" section. This list is continually updated as more CCS open throughout the course of the trial.
How are Continuing Care Sites (CCS) set up?
CCS are set up routinely by the neoGASTRIC Coordinating Centre; however, it can take some time to complete the setup process. Please inform the neoGASTRIC Coordinating Centre of any units to which you commonly transfer infants so that we can start this process early.
The neoGASTRIC team will contact the Research & Development teams at identified CCS locations. Data collection at a CCS cannot commence until the necessary regulatory approvals are obtained. If a baby is transferred to a neoGASTRIC recruitment site, data collection is permitted.
What documents will sites require to be set-up as a Continuing Care Site?
If sites are interested in becoming Continuing Care Sites, they will be required to arrange the necessary capability and capacity. Additionally, they must localise and sign the Organization Information Document. Staff at Continuing Care Sites do not need to be GCP trained to carry out their tasks, as they will not be involved in data entry. Furthermore, a delegation log is not required for Continuing Care Sites.
What data does a continuing care site (CCS) collect?
The main responsibility of a CCS is to continue with the infant's allocated trial arm (to measure or not to measure gastric residual volumes) and to continue completing the daily feed log until the infant is transferred, discharged home, or reaches 44+0 gestational weeks.
A CCS will also be responsible to completing all other reporting forms when they become applicable, including:
- Infections and Gut Signs Form
- Incident Reporting Form
- Serious Adverse Event (SAE) Report
- Transfer/Discharge Form
- Withdrawal and Discontinuation Form
How do Recruiting sites coordinate transfers with Continuing Care site?
All registered Continuing Care Sites are listed in orange on the neoGASTRIC website under the "Sites" section. Once you become aware of a transfer, please contact the neoGASTRIC Coordinating Centre via email or phone to obtain contact details for the Continuing Care Site.
Please ensure you contact the LRN or the PI at the Continuing Care Site prior to the transfer if possible. Ensure the transfer pack is sent with the participants when a transfer occurs and make your contact details readily available for the staff at the Continuing Care Site.
How does a recruiting site retrieve the data back from a continuing care site?
Continuing Care Sites are asked to securely return all completed data collection forms to the recruiting site via secure email. The recruiting site's contact details are available via the Parent Information Sheet that is included in the Transfer Pack.
What happens when an infant is transferred to a unit that is not a continuing care site?
If an infant is transferred to a non-Continuing Care Site, please inform the neoGASTRIC Coordinating Team of the transfer via either phone or email. Data collection will not be possible for infants transferred to non-Continuing Care Sites. Therefore, when completing OpenClinica forms, please add updates/annotations indicating that the infant has been transferred to a non-Continuing Care Site. This will generate queries that the trial coordinating team will address and resolve.
