SPIRIT | CONSORT-Children and Adolescents 2025

Research reporting guidelines, such as SPIRIT (Standard Protocol Items for Randomized Trials) and CONSORT (Consolidated Standards of Reporting Trials) guidelines offers a standard way for authors to prepare protocols and reports for randomized controlled trials. These guidelines facilitate complete and transparent reporting, which in turn aids their critical appraisal and interpretation. Over the years, SPIRIT and CONSORT have led to improved reporting and better implementation of trials; however, specific elements for trials with children (from newborn babies to adolescents, detailing the intervention, drug dose and delivery, validity of the outcomes studied, etc.) are not included. Growing evidence suggests the need for additional and modified items specific to child health that factor in these unique considerations to improve reporting in child health randomized controlled trials and reduce research waste.

In collaboration with members of the SPIRIT and CONSORT Group, we are extending the current SPIRIT and CONSORT statements and are developing a checklist of essential reporting items that authors should include when writing child health randomized controlled trial protocols and reports. These new guidelines will be called SPIRIT-Children and Adolescents (SPIRIT-C) and CONSORT-Children and Adolescents (CONSORT-C). SPIRIT | CONSORT-C will comprise of reporting items that cover various key elements associated with child health trials that differ from adult trials. The development will involve the evaluation of current evidence from published guidelines and implementing expert, consumer, and knowledge user feedback to produce a checklist and supplementary Explanation and Elaboration (E&E) document.

This project seeks to (a) obtain consensus regarding the minimum items to be reported in child health randomized controlled trial protocols and reports, (b) develop a plan of research to develop guidelines for researchers on how to implement checklist items, and (c) plan a knowledge translation strategy to disseminate the SPIRIT | CONSORT-C guidelines and to ensure endorsement. By standardizing how researchers conduct trials in children, the SPIRIT | CONSORT-C guidelines may improve the safety, use and impact of clinical research.

View registrations on the Enhancing the Quality and Transparency of Health Research (EQUATOR) website:

• SPIRIT-C
• CONSORT-C