Building a Core Minimum Dataset for Paediatric Critical Care Trials

Why This Matters

Paediatric critical care research faces significant methodological challenges. Compared to adult populations, paediatric studies often involve smaller patient numbers, greater clinical heterogeneity, and diverse healthcare contexts across regions. These factors limit the ability to generate robust, generalisable evidence to guide care for critically ill children.

One major barrier is the lack of standardized baseline data collection across trials. Without alignment on core variables, comparing studies, pooling data, and conducting meta-analyses becomes difficult and inefficient.

Developing a harmonised Core Minimum Dataset (CMD) will improve consistency in trial design, strengthen data comparability, and accelerate high-quality evidence generation globally.

Our Goals

The primary aim of this project is to develop an internationally harmonised Core Minimum Dataset (CMD) for paediatric critical care trials.

Specifically, we aim to:

• Define a standardized set of essential baseline variables to be collected for every patient enrolled in paediatric critical care trials.
• Develop an open-access electronic Case Report Form (eCRF) aligned with the CMD.
• Align the paediatric CMD with the adult ICU CMD (currently in development) to support cross-population research and comparability.
• Promote global adoption of a practical, scalable, and research-ready data framework.

This initiative is designed to be inclusive, evidence-informed, and globally representative.

How We’re Doing It

This project follows a structured, multi-phase approach.

1. Scoping Review

We are conducting a comprehensive review of published paediatric critical care trials to identify commonly collected baseline variables and existing CRF-CMDs. This ensures the dataset builds on existing evidence and best practice.

2. Real-Time Delphi Survey

An international panel of PICU clinicians, researchers, trialists, and methodologists participates in a structured Delphi process to reach expert consensus on which variables should be included in the CMD.

3. eCRF Development

Based on consensus outcomes, we are developing a standardized, interoperable electronic Case Report Form (eCRF). The tool will be user-friendly, adaptable to diverse settings, and suitable for global implementation.

This phased approach ensures methodological rigor, stakeholder engagement, and practical feasibility.

How You Can Help

To ensure this initiative is truly global and representative, we are actively seeking contributions from PICU healthcare professionals, researchers, and research networks across all regions.

You can support this project by:

• Sharing Existing CRFs or CMDs: Contribute templates and commonly recorded variables from your institution or network.
• Assisting with Data Extraction: Help review published PICU trials and extract baseline variables for analysis.
• Mapping Variables: Compare extracted data and existing CRFs to identify harmonization opportunities.
• Participating in the Delphi Panel: Join structured consensus rounds to define core variables.
• Advocating and Engaging: Share this initiative within your professional networks to broaden global participation.

Your expertise is essential to ensuring the CMD is practical, relevant, and applicable across diverse healthcare systems.

Expected Impact

A standardized Core Minimum Dataset will:

• Reduce duplication and inefficiencies in trial design.
• Improve data comparability across studies and regions.
• Enable data pooling and high-quality meta-analyses.
• Accelerate evidence generation for paediatric critical care.
• Strengthen global collaboration and research transparency.

Ultimately, this initiative aims to improve outcomes for critically ill children by ensuring that research data are harmonized, comparable, and actionable worldwide.