The Paediatric Intensive Care Adaptive Platform Trial (PIVOTAL): Turning Pediatric Critical Care Practice Into...

To describe the rationale, design, and implementation of the Paediatric Intensive Care Adaptive Platform Trial (PIVOTAL), a novel approach to embed adaptive clinical research within routine pediatric critical care practice.

Prospective, multicenter, Bayesian adaptive platform trial developed by the U.K. Paediatric Critical Care Society Study Group (PCCS-SG) and funded by the U.K. National Institute for Health and Care Research Health Technology Assessment program.

A minimum of 20 of the 33 PICUs across the United Kingdom that participating in the PCCS-SG research network.

Critically ill children admitted to a PICU requiring support for one or more organ systems.

Eligible patients will be randomized across multiple concurrent intervention domains. Each domain will test clinically relevant therapies where practice variation and evidence gaps exist. The adaptive Bayesian design allows dynamic modification of randomization ratios, dropping of inferior interventions, and addition of new domains over time.

The primary outcome, common to all domains, is days alive and free of organ support to day 30. Trial efficiency and inclusivity are enhanced using routinely collected national registry data from the Paediatric Intensive Care Audit Network, real-time electronic health record integration, and a proportionate consent model. Extensive statistical simulations will inform decision rules for superiority, futility, and equivalence.

PIVOTAL aims to bridge the gap between clinical care and research, providing a sustainable infrastructure to deliver timely, inclusive, and practice-changing evidence in pediatric critical care. Recruitment started in March 2026.