{
  "abstract": "Paediatric randomised controlled trials (RCTs) are key to evaluating new and existing interventions that can improve health outcomes in newborns, infants, children, and adolescents (aged 0-19 years). Well reported RCT protocols facilitate the planning and implementation of trials that generate high quality, reproducible evidence, and strengthen the foundations of paediatric healthcare decisions and ultimately improve patient outcomes. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2025 statement contains a checklist of essential reporting items and an explanation and elaboration paper. However, SPIRIT 2025 does not consider important elements that are unique to paediatric RCT protocols. As a paediatric extension to SPIRIT, we developed the SPIRIT-Children and Adolescents (SPIRIT-C) 2026 checklist, which this explanation and elaboration paper accompanies. We adopted a group writing approach to prepare this explanation and elaboration paper, and involved key partners with lived experience relevant to paediatric clinical trials, including family caregivers, trialists, child health researchers, clinicians, journal editors, and methodologists. This explanation and elaboration paper presents examples, explanations, and key elements for the 17 new SPIRIT-C 2026 reporting items; paediatric considerations with good reporting examples for six SPIRIT 2025 items; and a glossary. This paper also promotes the reporting of methodological rigor, patient safety, promotes a patient oriented approach, and facilitates the generation of high quality, reproducible trial evidence that will strengthen paediatric practice and policy decisions and ultimately improve patient outcomes.",
  "authors": [
    {
      "affiliations": [
        "Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada"
      ],
      "name": "Ami Baba"
    },
    {
      "affiliations": [
        "INFORM RARE Research Network, Ottawa, ON, Canada"
      ],
      "name": "Maureen Smith"
    },
    {
      "affiliations": [
        "School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada"
      ],
      "name": "Beth K Potter"
    },
    {
      "affiliations": [
        "Department of Medicine, Women’s College Research Institute, University of Toronto, Toronto, ON, Canada"
      ],
      "name": "An-Wen Chan"
    },
    {
      "affiliations": [
        "Ottawa Hospital Research Institute, Ottawa, ON, Canada"
      ],
      "name": "David Moher"
    },
    {
      "affiliations": [
        "Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada",
        "Department of Pediatrics, Division of Adolescent Medicine, The Hospital for Sick Children, Toronto, ON, Canada",
        "Department of Pediatrics, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada",
        "Institute of Clinical Evaluation Sciences (ICES), Toronto, ON, Canada",
        "Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada"
      ],
      "name": "Alene Toulany"
    },
    {
      "affiliations": [
        "SPIRIT | CONSORT-Children and Adolescents Family Caregiver Advisory Group, Toronto, ON, Canada"
      ],
      "name": "Amanda Doherty-Kirby"
    },
    {
      "affiliations": [
        "Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain",
        "Universitat Internacional de Catalunya, Immaculada, Barcelona, Spain",
        "European Young Person’s Advisory Group Network"
      ],
      "name": "Begonya Nafria Escalera"
    },
    {
      "affiliations": [
        "Division of Epidemiology, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada"
      ],
      "name": "Catherine Stratton"
    },
    {
      "affiliations": [
        "Neonatal Medicine, School of Public Health and Centre for Paediatrics and Child Health, Imperial College London, Chelsea and Westminster Hospital campus, London, UK"
      ],
      "name": "Chris Gale"
    },
    {
      "affiliations": [
        "Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada"
      ],
      "name": "Colin Macarthur"
    },
    {
      "affiliations": [
        "University Hospital of Montpellier, Child and Adolescent Psychiatry (MPEA1), Saint Eloi Hospital, Montpellier, France",
        "INSERM CESP U1018, Villejuif, France"
      ],
      "name": "Diane Purper-Ouakil"
    },
    {
      "affiliations": [
        "Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK"
      ],
      "name": "Edmund Juszczak"
    },
    {
      "affiliations": [
        "Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada",
        "Edwin S.H. Leong Centre for Healthy Children, University of Toronto, ON, Canada"
      ],
      "name": "Eyal Cohen"
    },
    {
      "affiliations": [
        "TEDDY European Network of Excellence for Paediatric Research, Bari, Italy"
      ],
      "name": "Giorgio Reggiardo"
    },
    {
      "affiliations": [
        "Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK"
      ],
      "name": "Jennifer Preston"
    },
    {
      "affiliations": [
        "Department of General Pediatrics and Pediatric Infectious Diseases, Necker Hospital for Sick Children, Université Paris Cité, Paris, France",
        "Center for Research in Epidemiology and Statistics, Université Paris Cité, Paris, France"
      ],
      "name": "Jérémie F Cohen"
    },
    {
      "affiliations": [
        "Division of Immunology and Allergy, Department of Paediatrics, The Hospital for Sick Children, Toronto, ON, Canada"
      ],
      "name": "Julia Upton"
    },
    {
      "affiliations": [
        "Department of Development and Regeneration, KU Leuven, Leuven, Belgium",
        "Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium",
        "Department of Hospital Pharmacy, Erasmus MC, Rotterdam, Netherlands"
      ],
      "name": "Karel Allegaert"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Faculty of Medicine, BC Children’s Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada"
      ],
      "name": "Katelynn Boerner"
    },
    {
      "affiliations": [
        "Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA"
      ],
      "name": "Kayur Mehta"
    },
    {
      "affiliations": [
        "Hospices Civils de Lyon, NICU Femme Mere Enfant Hospital",
        "EMET, LBBE, University of Lyon 1, Lyon, France"
      ],
      "name": "Kim An Nguyen"
    },
    {
      "affiliations": [
        "SPIRIT | CONSORT-Children and Adolescents Family Caregiver Advisory Group, Toronto, ON, Canada",
        "CHEO Research Institute, Ontario Child Health Support Unit, Ottawa, ON, Canada"
      ],
      "name": "Kimberly Courtney"
    },
    {
      "affiliations": [
        "Alberta Research Centre for Health Evidence, Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada"
      ],
      "name": "Lisa Hartling"
    },
    {
      "affiliations": [
        "Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada",
        "Li Ka Shing Knowledge Institute, St Michael’s Hospital, Unity Health Toronto, Toronto, ON, Canada"
      ],
      "name": "Menelaos Konstantinidis"
    },
    {
      "affiliations": [
        "Children Heart Center, Skane University Hospital, Lund, Sweden"
      ],
      "name": "Michal Odermarsky"
    },
    {
      "affiliations": [
        "Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada",
        "Department of Psychiatry, University of Toronto, Toronto, ON, Canada"
      ],
      "name": "Nancy J Butcher"
    },
    {
      "affiliations": [
        "Population Health Sciences Institute, Newcastle University, Newcastle, UK",
        "NIHR Innovation Observatory, Newcastle University, Newcastle, UK"
      ],
      "name": "Niina Kolehmainen"
    },
    {
      "affiliations": [
        "Children’s Hospital of Eastern Ontario Research Institute and Department of Pediatrics, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada"
      ],
      "name": "Patricia E Longmuir"
    },
    {
      "affiliations": [
        "Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada"
      ],
      "name": "Peter J Gill"
    },
    {
      "affiliations": [
        "Department of Pediatrics Maastricht University Medical Centre and School of Health Professions Education, Maastricht University, Netherlands"
      ],
      "name": "Piet Leroy"
    },
    {
      "affiliations": [
        "ICON, Langen, Germany"
      ],
      "name": "Reinhard Feneberg"
    },
    {
      "affiliations": [
        "The INCLEN Trust International, New Delhi, India"
      ],
      "name": "Ramesh Poluru"
    },
    {
      "affiliations": [
        "Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada",
        "Division of Infectious Diseases, The Hospital for Sick Children, Toronto, ON, Canada",
        "Department of Pediatrics, Faculty of Medicine, University of Toronto, Toronto, ON, Canada"
      ],
      "name": "Shaun K Morris"
    },
    {
      "affiliations": [
        "Division of Pediatric Pain, Palliative and Integrative Medicine, University of California at San Francisco, San Francisco, CA, USA"
      ],
      "name": "Stefan J Friedrichsdorf"
    },
    {
      "affiliations": [
        "SPIRIT | CONSORT-Children and Adolescents Family Caregiver Advisory Group, Toronto, ON, Canada",
        "Canadian PKU and Allied Disorders (CanPKU+), Toronto, ON, Canada"
      ],
      "name": "Tanya Chute Nagy"
    },
    {
      "affiliations": [
        "Department of Pediatrics, College of Medicine, University of Saskatchewan, SK, Canada"
      ],
      "name": "Terry P Klassen"
    },
    {
      "affiliations": [
        "Maternal Infant Child and Youth Research Network (MICYRN), Vancouver, BC, Canada"
      ],
      "name": "Thierry Lacaze-Masmonteil"
    },
    {
      "affiliations": [
        "Department of Neonatology, Emma Children’s Hospital, Amsterdam University Medical Centers, Amsterdam, Netherlands",
        "Amsterdam Reproduction and Development, Amsterdam, Netherlands"
      ],
      "name": "Wes Onland"
    },
    {
      "affiliations": [
        "Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada"
      ],
      "name": "Martin Offringa"
    }
  ],
  "title": "SPIRIT-C 2026 explanation and elaboration: recommendations for enhancing the reporting and usefulness of paediatric randomised trial protocols",
  "uid": "aeebda7c-98a5-5dd9-ae09-ee581173e0b3"
}