REC reference: 25/NI/0113

ISCRTNISRCTN24287322

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.

Associate PI Scheme study Badge
API scheme figures (1)
 

 

API Scheme_infographic_v5.2_no bleed (May 2023)_page-0001
 

 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. 

balloon

 

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. 

WashT

 

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. 

BASE

 

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.

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!
HrI image
 

 Please click on the image below to view the newsletter in a larger size. 

DEXTA Newsletter_Jul-2026 

Please get in touch via dexta@nottingham.ac.uk if you would like to be added to the mailing list.

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.