PIVOTAL
Research type
Research Study
Full title
Paediatric Intensive Care Adaptive Platform Trial (PIVOTAL)
IRAS ID
1012497
Contact name
Mark Peters
Contact email
Sponsor organisation
Great Ormond Street Hospital
ISRCTN Number
ISRCTN22370354
Research summary
There is an urgent need to improve treatment for critically ill children on paediatric intensive care units (PICUs). Randomised controlled trials (RCTs) provide the best evidence, but the way we do these trials is slow and expensive. It usually takes several years for enough children to be included in a study before we have enough information to tell which treatment is safer.
A randomised adaptive platform is an alternative way of doing trials. It allows multiple treatments and research questions to be tested at the same time under one platform. An important feature is that the trial can 'adapt' as it goes along. For example, new treatments or research questions can be added when they become available. The results are also looked at during the trial, not just at the end. This means treatments that are working better in the trial can be given to more patients sooner, while those that are less safe or less effective can be stopped earlier.
PIVOTAL will take place in 20 UK NHS PICUs and aims to enrol up to 12,900 patients. Recruitment is expected to begin in January 2026. The primary objective is to evaluate multiple widely-used treatments at the same time to improve clinical care for critically ill children on PICU, initially focusing on evaluating three treatment areas.
Patients who meet the platform-level eligibility will then be assessed against specific treatment area eligibility criteria. Those eligible for one or more treatment areas will be enrolled into the trial. Patients will be followed up to 6-months after enrolment.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
25/EE/0214
Date of REC Opinion
4 Dec 2025
REC opinion
Further Information Favourable Opinion