TRUFFLE
Trial of randomized umbilical and fetal flow in Europe
TRUFFLE, the trial of randomized umbilical and fetal flow in Europe, is a partnership of leading European perinatal centres undertaking studies in high risk perinatology and fetal growth restriction. Learn more
The original TRUFFLE 1 study has led to important findings in the delivery of growth-restricted fetuses, and TRUFFLE 2 is now underway as we conduct a feasibility study. Read more
We could not conduct this important research into managing small growing babies if it were not for willing participants. Click here to read about becoming a participant in the TRUFFLE2 Study. Read more
Now that we are into our final year of recruitment to the TRUFFLE Study, we will unfortunately not be opening any new sites. Click here to see a list of sites recruiting to the TRUFFLE Study. Read more
We are proud to announce that on Saturday January 20th 2024, the Imperial Team will host a TRUFFLE 2 Investigators meeting in London. As we are now in our final year of recruitment, the aim of the meeting will be to boost recruitment numbers, discuss the sub-studies data, and troubleshoot any problems arising across sites.
This month Professor Valensise and his team from Rome Policlinico hosted a meeting focusing on Maternal Cardiovascular research for all TRUFFLE centres to attend. There was huge attendance at this event with over 70 investigators able to join in person. We were able to review the haemodynamics sub-study within TRUFFLE, to discuss and learn about different cardiovascular machines (the USCOM, Vicorder, and Arteriograph machines) as well as hear from clinicians from different units presenting related research.
We have now reached 3000 pre-eligible participants in the TRUFFLE2 Study, and have 350 randomised patients! Thank you to all of the patients and staff at the recruiting sites for contributing to this. We are currently recruiting across 51 sites in 12 different countries; The UK, Austria, Belgium, Czech Republic, Estonia, Germany, Italy, Norway, Spain, Sweden, Switzerland, and now Poland!
This month the Imperial Team were able to host the Autumn Investigators meeting in London. There was a broad attendance from 12 recruiting sites, both from the UK and outside of the UK, as well as the Trial Management team from Cardiff. We had a further 38 people join and participate online, with representation from 25 sites. It was a very successful meeting and served as a wonderful chance to discuss improvements and developments within the trial, receiving input from many different sites.
The next TRUFFLE 2 Investigator meeting will be held in person on Saturday 7th May 2022. This meeting will take place in Klagenfurt and is hosted by Philipp Klaritsch and Kurt Hecher. This event will also include a Fetal Growth Restriction course on Friday 6th May open to attendees outside of those working on TRUFFLE, as well as the TRUFFLE study meeting. The aim of the meeting is to discuss the progress of the TRUFFLE2 study and any trial changes. As always, we hope to see as many of you there as possible!
This month we had our first in-person meeting of the TRUFFLE group since Leuven in March 2019. The Investigator meeting was held on Saturday 9th October 2021, hosted by Dr Julia Binder in Vienna. It was a brilliant chance to discuss the progress of the trial, as well as hear about upcoming sub-studies and recently published papers. See below some photos of the event.
We have now reached nearly 1000 pre-eligible participants in the TRUFFLE2 Study, and have 100 randomised patients! Thank you to all of the patients and staff at the recruiting sites for contributing to this. We are currently recruiting across 44 sites in nine different countries; The UK, Austria, Czech Republic, Germany, Italy, Norway, Sweden, Switzerland, and now Estonia!
The TRUFFLE2 Trial now has 28 sites open for recruitment. There are live sites across Europe including from the UK, Austria, Czech Republic, Italy, Germany, Norway, Switzerland, and Sweden. There are over 150 pre-eligible participants recruited to the trial, and over 20 patients have now been randomised. As always, live updates will be shared on our Twitter page!
In January 2021 the TRUFFLE group hosted a short course on Fetal Growth Restriction, sponsored by GE Healthcare. International experts came together to give an intensive course on FGR diagnosis, management and outcome. The course was aimed at all involved in high risk perinatal care; fetal medicine specialists, obstetricians, neonatologists, radiologists, sonographers and midwives. The event, which was chaired by Professors Christoph Lees (UK) and Philipp Klaritsch (Austria), was attended by over 1000 participants from all over the world. Speakers included Kurt Hecher (Hamburg), Amar Bhide (London), Silvia Lobmaier (Munich), Katia Bilardo (Netherlands), Tamara Stampalija (Trieste), Raf Napolitano (London), Enrico Ferrazzi (Milan), Neil Marlow (London), and Herbert Valensise (Rome).
In October 2020 the TRUFFLE2 Investigators meeting took place as a webinar. Speakers included PI Philipp Klaritsch, Clinical Research Fellow Bonnie Mylrea-Foley, and PI Raf Napolitano. It was a chance to update all of the TRUFFLE centres on live site updates and recruitment, as well as hear about the process of Doppler Quality Control within TRUFFLE2, and an update on the Biomarkers Study.
The TRUFFLE 2 Trial went live on the 1st October with lead site Queen Charlotte's and Chelsea Hospital open for recruitment. University Hospital Jena and Tor Vergata University Policlinico Casilino Rome, have also opened for recruitment, with many more due to open over the coming weeks. The first pre-eligible participant has already been recruited. Live updates will be shared on twitter!
In June 2020 the TRUFFLE team hosted another Investigators meeting as a webinar. This included an update on the progress of the study, especially in view of COVID-19, and of changes to the planned Klagenfurt meeting. There was also a live demonstration of entering a patient into the CASTOR database, and the floor was then open for attendees to ask questions and have discussions. We are now planning a TRUFFLE meeting in Klagenfurt on the 24th of October 2020 (with an FGR Course on the 23rd October, which is open to those working outside of the TRUFFLE study). The TRUFFLE team try to meet in person roughly every 6 months in various locations, this has been postponed due to Covid-19, but we are hoping to be able to go ahead with this new date.
The TRUFFLE team try to meet roughly every 6 months in various locations, in order to discuss the international TRUFFLE2 trial. The next TRUFFLE meeting was scheduled for 17-18 April 2020 and was to be held in Klagenfurt, Austria. In view of the COVID-19 situation, and given advice from various Governments and travel restrictions by Universities and Hospitals, unfortunately we had no choice but to postpone this meeting until late 2020. Instead of the Klagenfurt TRUFFLE meeting that was planned for this time, this April the TRUFFLE team held an Investigators Webinar, so that all Investigators could safely join from accross Europe. Thank you so much to all of our TRUFFLE sites that were able to join, and for those centres that couldn’t join us but instead sent their updates. Another webinar will be scheduled for later in the year when we will have revised Klagenfurt meeting dates and more detail in relation to starting recruitment and quality control.
The TRUFFLE 2 study officially started in December 2019 and is in its final set-up period. Patient recruitment will run for two years starting in June 2020, followed by a further 2 years of neonatal follow-up. The study will aim to randomise almost 1600 women with late onset growth restriction to either immediate delivery (once cerebral redistribution is identified) or delayed delivery (based on cCTG changes).
A total of 53 centres will be taking part from the UK, Italy, Germany, Austria, Belgium, Sweden, Norway, Spain, Czech Republic, Switzerland, Russia and Estonia.
TRUFFLE 2 has taken over 5 years to plan, including multiple international meetings where collaborators have reached consensus on methodology. There will be a TRUFFLE collaborators “kick-off” meeting in April in Klagenfurt, and these meetings will continue at regular intervals throughout to study to ensure cohesion and communication between centres.
From December 2019 the study in the UK is being funded for 5 years by a £2.5m grant from the NIHR, which includes funds for 2.5 research midwives to co-ordinate UK centres. In addition, Imperial Health Charities have awarded a grant for a Clinical Research Fellow to co-ordinate study set up. A number of other funding applications are being submitted, both national applications for other countries and project grants for parallel studies planned such as maternal cardiovascular health and biomarkers.
Bronacha Mylrea-Foley, the clinical research fellow for TRUFFLE 2, along with Olive Adams, the TRUFFLE 2 research midwife, started visiting study centres in September. These visits continue with Jenny Goodier, another research midwife who has joined the TRUFFLE team. Their visits serve to disseminate the study plan to the research teams within each unit and ensure all sites are ready for the project start date. They have further visits lined up and aim to visit all European and UK study centres before recruitment begins.
Some photos from the recent TRUFFLE study meeting in Leuven, Belgium. Thanks to Dr Jute Richter and Professor Roland DeVlieger for hosting, and to all who attended for an excellent meeting.
The 2018 TRUFFLE study meeting took place in Turin, hosted by T. Todros and E. Bertino. Topics discussed include:
A selection of photos from the TRUFFLE study Berlin meeting in 2017.
Check out photos of the venue in Berlin for the TRUFFLE meeting 2nd December at Dr Bine Arabin' Foundation, visited by Christoph Lees today.
Dr Raf Napolitano was awarded by University College London Hospital's NHS Foundation Trust a research grant of £25,000 for one year to fund 50% of a Clinical Research Fellowship salary for the implementation of the TRUFFLE 2 Study at University College London Hospital.
We have published this new website to give information on the TRUFFLE study, our goals, and news about the ongoing feasibility study!
