A “gold standard” randomised controlled trial of Omeprazole drug treatment for all OA babies.
To provide solid evidence as to whether treating all OA babies with an anti-reflux drug such as Omeprazole is on balance helpful to them. A key measure, but not the only one, is the extent to which those receiving the Omeprazole experience fewer strictures.
Despite the existence of an international guideline suggesting Omeprazole treatment, there is no “gold standard” evidence which shows this is beneficial, and some research which indicates it may well cause problems.
The Feasibility study stage started in Spring 2021. The main phase of the trial is expected to be underway during Summer 2022 and run for some 6 years.
Throughout England. Many of the specialist NHS centres at which OA babies have surgery are expected to be involved, with the chance to take part being offered to the parents of the majority of OA babies born in England.
The trial is led by Associate Professor Nigel Hall (Southampton University) and fellow paediatric surgeon Mr Iain Yardley (Evelina Hospital). Oxford University’s National Perinatal Epidemiology Unit is organising much of the detail of the trial. The feasibility study has been undertaken by researchers at Liverpool university. Academic staff at Nottingham university are also involved. TOFS is a signatory to the collaboration agreement. The trial is funded by the English National Institute for Healthcare Research.
TOFS is Patient and Public Participation partner for the trial. We have been involved since 2019, and have made numerous suggestions to try to make the detail of the trial as patient-friendly as possible. About 20 TOFS members took part in detailed interviews as part of the feasibility study, and TOFS members make up the trial’s “Parent Advisory Group.
Within the UK, it is very likely that surgeons will take note of the findings. We anticipate that they will either:
It is expected that the trial’s outcomes will be used to bolster the ESPGHAN / NASPGHAN recommendations – or revise them.