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SPIRIT-Children and Adolescents (SPIRIT-C) 2026 extension statement: enhancing the reporting and usefulness of

Ami Baba1, Maureen Smith2, Beth K Potter3

  • 1Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada.

The Lancet. Child & Adolescent Health
|June 12, 2026
PubMed

Insights

New guidelines called SPIRIT-Children and Adolescents (SPIRIT-C) 2026 improve reporting for paediatric randomised controlled trials (RCTs). These guidelines ensure comprehensive details for better planning and implementation of child-focused research.

Area of Science:

  • Clinical Trials Methodology
  • Pediatric Research
  • Health Research Reporting Standards

Background:

  • Randomised controlled trial (RCT) protocols are crucial for evaluating trial design and safety.
  • Paediatric RCT protocols often lack essential details regarding age-specific adjustments, developmental appropriateness, and participant well-being.
  • These omissions hinder the effective planning and execution of trials involving children and adolescents.

Purpose of the Study:

  • To develop comprehensive reporting guidance for paediatric RCT protocols involving participants aged 0-19 years.
  • To create a paediatric extension to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2025 guidelines.
  • To enhance the quality and transparency of paediatric clinical trial protocols.

Main Methods:

  • Utilized the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network's methodological framework.
  • Generated candidate reporting items from literature review and incorporated input from a Youth Advisory Group and a Family Caregiver Advisory Group.
  • Conducted an international Delphi study, a consensus meeting, group writing, and pilot testing to develop the SPIRIT-Children and Adolescents (SPIRIT-C) 2026 guideline.

Main Results:

  • Developed SPIRIT-Children and Adolescents (SPIRIT-C) 2026, a checklist with 17 new reporting items for paediatric RCT protocols.
  • Four items were generated by youth, and six were endorsed by youth, ensuring participant-centric perspectives.
  • An accompanying explanation and elaboration paper provides detailed guidance and examples for reporting.

Conclusions:

  • SPIRIT-C 2026 offers a minimum set of reporting items for paediatric RCT protocols, benefiting diverse stakeholders.
  • Implementation of SPIRIT-C 2026 is expected to improve the quality and utility of protocols for trials involving children and adolescents.
  • This guideline aims to foster high-quality paediatric trials from birth through adolescence.

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