REC reference: 25/NI/0113
ISCRTN: ISRCTN24287322
Clinical Trials Unit: Nottingham Clinical Trials Unit
Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
Funder: National Institute for Health Research (NIHR)
Recruitment Target: 240
Overall Trial End Date: 30 April 2030
MHRA Approval Date: 10-Oct-2025
HRA Approval Date: 20-Oct-2025
REC Approval Date: 06-Oct-2025
To express an interest for your hospital to take part, click below:
DEXTA Expression of Interest Form
Study Resources
Training Materials
API Scheme
DEXTA is registered with NIHR Associate Principle Investigator Scheme
Click here to read more about the API scheme
We are delighted to announce that DEXTA is registered with NIHR Associate Principle Investigator Scheme and we are open to accept applications from 02-Jan-2026.
Please identify trainees who would be interested in enrolling. Upon successful registeration, applicants will be able to register to be an Associate PI for DEXTA, having obtained approval from their local PI.
To register, please visit Apply to be Associate Principal Investigator and please inform the DEXTA team before submitting a registration form.
For DEXTA PI’s this could have the benefit of providing additional support in delivering the study, whilst allowing trainees to incorporate research into their training. The scheme is open to trainees, nurses, and allied health professionals, allowing them to gain official recognition for research activity (it is not open to those whose roles are already research funded). The scheme allows others to work alongside the PI, however the PI always retains oversight of the trial.
Involves: A 6-month commitment to the trial is required to gain associate PI status, and NIHR provide a checklist of tasks to be completed during those 6 months. These activities are all logged on the NIHR learn platform. Upon completion of the scheme, you will receive a certificate. We would love to share this news on our site newsletters and our 'X' account @DEXTA_NCTU if you consent to us sharing this.
Co-enrolment
We now have an offiical coenrolment agreement in place with the BALLOON trial! Please note, the IMP cannot be given at the same time.

We now have an official coenrolment agreement in place with the WashT trial! As this trial is an investigational trial, babies can be coenrolled during the 5 day infusion period.

We now have an official coenrolment agreement in place with the BASE trial! This is a CTIMP trial however because it uses sodium bicarbonate which is routinely given in neonates, we permit the use of the IMPs at the same time if necessary.

We now have an official coenrolment agreement in place with the WHEAT trial. This agreement also means that co-enrolment with the observational MAGPIE 2 study is permitted, provided the participant is also enrolled in WHEAT.

Co-enrolment
| Trial | Agreement progress |
| BALLOON |
Agreement in place, co-enrolment PERMITTED |
| BASE |
Agreement in place, co-enrolment PERMITTED and IMPs CAN be used at the same time |
| WHEAT |
Agreement in place, co-enrolment PERMITTED |
| WashT |
Agreement in place, co-enrolment PERMITTED |
| FIT-PIV / FIT-05 |
Co-enrolment is NOT PERMITTED |
| GenoMICC |
Observational so co-enrolment PERMITTED |
| Surfsup |
Recruitment due to stop soon, so co-enrolment not explored |
| Happi |
Discussions in progress |
| MAGPIE-2 |
Agreement in place for WHEAT, so co-enrolment PERMITTED provided the participant is also enrolled in WHEAT. |
| RePHyNe |
Observational so co-enrolment PERMITTED |
| The 22 Week Study |
Discussions in progress |
| Womb to World |
Single centre study, so co-enrolment is NOT PERMITTED |
| COLLABORATE |
Discussions in progress |
| TEARDROPS |
Observational so co-enrolment PERMITTED |
| Genomicc |
Observational so co-enrolment PERMITTED |
Site News
Celebrating progress at Hull Royal Infirmary!
The DEXTA team at Hull Royal Infirmary are celebrating their contribution to research into pain management for ventilated preterm babies.
Hull Royal Infirmary opened as a DEXTA location on 27 February 2026, with their first baby recruited on 29 March 2026. The team have now recruited three babies, contributing to DEXTA’s overall recruitment and helping researchers improve pain management for the vulnerable babies receiving neonatal care.
DEXTA, the DEXmedetomidine Trial of Adjunct Treatment with Morphine, is investigating whether adding dexmedetomidine to morphine can reduce the amount needed to keep ventilated preterm babies pain-free, while reducing morphine-related adverse effects.
In July, DEXTA Trial Manager Megan and Quality Assurance Manager Fran visited the Hull team for an on-site monitoring visit. The visit provided an opportunity to review progress and data quality, meet the research team and celebrate their work.
The Hull team have been incredibly responsive and enthusiastic throughout their involvement in DEXTA. Their commitment to recruitment, careful data collection and engagement with the trial team has made them a fantastic site to work with.
Some quotes from the Hull team:
'We are extremely proud to have been the first centre to recruit to DEXTA and to remain one of the highest recruiting units. This achievement reflects the dedication of our research and clinical nursing teams, the enthusiasm of our medical team, and, most importantly, the incredible support of parents who have embraced the study and its potential to improve outcomes for babies in the future.' Dr Mahmoud Soultan and Dr Ourania Pappa (the Hull Principal Investigator).
'Being an Associate PI for DEXTA has been a fantastic opportunity to develop my research experience while contributing to a study that could help shape future neonatal care when it comes to pain management and neurodevelopment. It is exciting to be part of such a collaborative team.' Donna Casson, Associate PI.
'We feel privileged to be part of another important study for our NICU babies.
Research is so important and especially within this small group of babies where every day practices change, and more evidence is needed to enable us to implement change to best care for these babies. We would also like to acknowledge the drive and dedication of our PI Dr Ourania Pappa, this is the first time she has been the PI for a study, and she has been monumental in pushing forward this important trial.' Paediatric & Neonatal Research Nurses Melony Bowdler-Hayes & Leanne Sherris, clinical trials assistant Angela Harvey and NICU nurse Ellie Adamson.
The DEXTA team thank everyone at Hull Royal Infirmary who has contributed so far. Every baby recruited is an important contribution to the research, and the enthusiasm and commitment of teams like Hull are essential to DEXTA’s success.
Thank you to the Hull team for everything you are doing for DEXTA!

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Safety run in period:
As part of the MHRA requirements for the trial, a safety run-in period was undertaken, during which safety data were collected and reviewed against predefined stopping criteria set out in the current protocol (Version 3.0, 19 March 2026).
The DMC met on 11 August 2026 and undertook a detailed review of the safety data available from this period. Importantly, the DMC identified no safety concerns from the data reviewed, and none of the predefined stopping criteria were met.
The DMC also confirmed that there were no other reasons to suggest that recruitment should be suspended or that the trial should close prematurely. On the basis of the data reviewed, the DMC has recommended that the trial continues according to the current protocol, with no changes.
The DMC has subsequently provided a letter of support confirming this recommendation.
We appreciate that the MHRA-requested safety run-in may have prompted some understandable questions or caution around the continuation of the trial. We hope that the outcome of this independent review provides reassurance to participating sites and their research teams that the safety data reviewed to date have not raised concerns requiring any change to the conduct of the trial.
Recruitment and trial activities should therefore continue as planned, in accordance with the current protocol and site procedures.