PREVENT Study So Far
The PREVENT study was launched with meetings held between 16 to 18 November 2019 in Bangalore and from 21 to 22 November 2019 in Chennai. These meetings, attended by experts from India and the UK, aimed to engage with the various components of the trial in depth. These interactive sessions benefitted from the inputs received from experts such as Prof (Sir) Arulkumaran Sabaratnam, Prof (Dame) Tina Lavender, Prof Alex Haezell, Dr Harshad Sanghvi, Dr Ronit Pressler, Prof Charles Newton and Dr Helen Cross among others in making the trial protocol and process stronger.
Drawing from the inputs during these meetings, a dry run was conducted in all the centres (Calicut and Bangalore) starting from 3 January, for about 6 weeks. This was an opportunity to understand the various challenges in data collection, in multiple levels, such as the data collection process, the tool and the RedCap platform we use. We held very frequent meetings to discuss the analysis reports from the team in London. These were very helpful and a great learning for the whole team, and we were able to deal with most of the challenges we faced, for instance, the percentage of missing data points was reduced to near zero towards the end of 6 weeks.
In order to discuss these learnings, and at the same time to resolve the persisting challenges, another meeting was held prior to the commencement of the recruitment. One part of the meeting was held in Calicut where the emphasis was on the Obstetrics components on 21 and 22 February 2020. This meeting engaged with all the four care bundles of the PREVENT study. The various challenges faced during the dry run phase of the study was discussed, followed by the identification of pragmatic solutions for the same which were appropriate for the various sites. This was possible due to the participation of the Principal Investigators and other Investigators from the study sites. We were also able to plan for the commencement of the recruitment in these sites. It was also a good opportunity for the research team to engage with the hospital staff, whose involvement would be vital for the success of the study.
This Obstetrics meeting in Calicut was followed by the neonatal training on 24 and 25 February 2020 in Calicut, which focused on an in-depth discussion of the PREVENT study protocol with an emphasis on the various neonatal protocols, NICHD (National Institute of Child Health and Human Development) neurological examination training for Hypoxic Ischemic Encephalopathy (HIE), as well as training on electroencephalography (EEG). These sessions were conducted for the faculty and postgraduate students by Dr Ronit Pressler, Dr Gabriel Variane, Dr Salah Basheer and Dr Sudhin Thayyil. Similar training was held in Bangalore on 26 and 27 February 2020.
“In the Indian health-care sector, we are dealing with outdated technologies. But while working with the PREVENT team, we got a chance to work with the latest technologies and a great opportunity to work with expert medical professionals which has helped me improve my professional knowledge and skills.”
On 1 March 2020, the PREVENT study recruitment began. However, on 19 March 2020, the study was temporarily halted in the context of the COVID-19 pandemic. The data collected will be considered as dry-run and will be subject to in-depth analysis. We are hoping to restart the study in full swing, as soon as the circumstances are conducive.
