SPIRIT-C 2026 explanation and elaboration: recommendations for enhancing the reporting and usefulness of paediatric randomised trial protocols

Ami Baba; Maureen Smith; Beth K Potter; An-Wen Chan; David Moher; Alene Toulany; Amanda Doherty-Kirby; Begonya Nafria Escalera; Catherine Stratton; Chris Gale; Colin Macarthur; Diane Purper-Ouakil; Edmund Juszczak; Eyal Cohen; Giorgio Reggiardo; Jennifer Preston; Jérémie F Cohen; Julia Upton; Karel Allegaert; Katelynn Boerner; Kayur Mehta; Kim An Nguyen; Kimberly Courtney; Lisa Hartling; Menelaos Konstantinidis; Michal Odermarsky; Nancy J Butcher; Niina Kolehmainen; Patricia E Longmuir; Peter J Gill; Piet Leroy; Reinhard Feneberg; Ramesh Poluru; Shaun K Morris; Stefan J Friedrichsdorf; Tanya Chute Nagy; Terry P Klassen; Thierry Lacaze-Masmonteil; Wes Onland; Martin Offringa

doi:10.1136/bmj-2025-085064

SPIRIT-C 2026 explanation and elaboration: recommendations for enhancing the reporting and usefulness of paediatric randomised trial protocols

Ami Baba
, Maureen Smith
, Beth K Potter
, An-Wen Chan
, David Moher
, Alene Toulany
, Amanda Doherty-Kirby
, Begonya Nafria Escalera
, Catherine Stratton
, Chris Gale
, Colin Macarthur
, Diane Purper-Ouakil
, Edmund Juszczak
, Eyal Cohen
, Giorgio Reggiardo
, Jennifer Preston
, Jérémie F Cohen
, Julia Upton
, Karel Allegaert
, Katelynn Boerner

Kayur Mehta, Kim An Nguyen, Kimberly Courtney, Lisa Hartling, Menelaos Konstantinidis, Michal Odermarsky, Nancy J Butcher, Niina Kolehmainen, Patricia E Longmuir, Peter J Gill, Piet Leroy, Reinhard Feneberg, Ramesh Poluru, Shaun K Morris, Stefan J Friedrichsdorf, Tanya Chute Nagy, Terry P Klassen, Thierry Lacaze-Masmonteil, Wes Onland, Martin Offringa^*

^*Corresponding author for this work

Pharmacy

The Hospital for Sick Children Research Institute
INFORM RARE Research Network
University of Ottawa
University of Toronto
Ottawa Hospital Research Institute
SPIRIT | CONSORT-Children and Adolescents Family Caregiver Advisory Group
Institut de Recerca Sant Joan de Déu
Imperial College London
University Hospital of Montpellier
University of Nottingham
TEDDY European Network of Excellence for Paediatric Clinical Research
University of Liverpool
Necker Hospital for Sick Children
The Hospital for Sick Children
KU Leuven
University of British Columbia
Johns Hopkins Bloomberg School of Public Health
University of Lyon 1
University of Alberta
Skåne University Hospital
Newcastle University
School of Health Professions Education (Maastricht)
ICON plc (Dublin)
The INCLEN Trust International
University of California at San Francisco
University of Saskatchewan
Maternal Infant Child and Youth Research Network (MICYRN)
Amsterdam UMC

Research output: Contribution to journal › Article › Academic › peer-review

Original language	English
Article number	e085064
Pages (from-to)	e085064
Journal	BMJ (Clinical research ed.)
Volume	392
DOIs	https://doi.org/10.1136/bmj-2025-085064
Publication status	Published - 24 Feb 2026

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10.1136/bmj-2025-085064

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SPIRIT-C 2026 explanation and elaboration
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Embargo ends: 24/08/26

Cite this

Baba, A., Smith, M., Potter, B. K., Chan, A.-W., Moher, D., Toulany, A., Doherty-Kirby, A., Escalera, B. N., Stratton, C., Gale, C., Macarthur, C., Purper-Ouakil, D., Juszczak, E., Cohen, E., Reggiardo, G., Preston, J., Cohen, J. F., Upton, J., Allegaert, K., ... Offringa, M. (2026). SPIRIT-C 2026 explanation and elaboration: recommendations for enhancing the reporting and usefulness of paediatric randomised trial protocols. BMJ (Clinical research ed.), 392, e085064. Article e085064. https://doi.org/10.1136/bmj-2025-085064

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title = "SPIRIT-C 2026 explanation and elaboration: recommendations for enhancing the reporting and usefulness of paediatric randomised trial protocols",

author = "Ami Baba and Maureen Smith and Potter, \{Beth K\} and An-Wen Chan and David Moher and Alene Toulany and Amanda Doherty-Kirby and Escalera, \{Begonya Nafria\} and Catherine Stratton and Chris Gale and Colin Macarthur and Diane Purper-Ouakil and Edmund Juszczak and Eyal Cohen and Giorgio Reggiardo and Jennifer Preston and Cohen, \{J{\'e}r{\'e}mie F\} and Julia Upton and Karel Allegaert and Katelynn Boerner and Kayur Mehta and Nguyen, \{Kim An\} and Kimberly Courtney and Lisa Hartling and Menelaos Konstantinidis and Michal Odermarsky and Butcher, \{Nancy J\} and Niina Kolehmainen and Longmuir, \{Patricia E\} and Gill, \{Peter J\} and Piet Leroy and Reinhard Feneberg and Ramesh Poluru and Morris, \{Shaun K\} and Friedrichsdorf, \{Stefan J\} and Nagy, \{Tanya Chute\} and Klassen, \{Terry P\} and Thierry Lacaze-Masmonteil and Wes Onland and Martin Offringa",

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Baba, A, Smith, M, Potter, BK, Chan, A-W, Moher, D, Toulany, A, Doherty-Kirby, A, Escalera, BN, Stratton, C, Gale, C, Macarthur, C, Purper-Ouakil, D, Juszczak, E, Cohen, E, Reggiardo, G, Preston, J, Cohen, JF, Upton, J, Allegaert, K, Boerner, K, Mehta, K, Nguyen, KA, Courtney, K, Hartling, L, Konstantinidis, M, Odermarsky, M, Butcher, NJ, Kolehmainen, N, Longmuir, PE, Gill, PJ, Leroy, P, Feneberg, R, Poluru, R, Morris, SK, Friedrichsdorf, SJ, Nagy, TC, Klassen, TP, Lacaze-Masmonteil, T, Onland, W & Offringa, M 2026, 'SPIRIT-C 2026 explanation and elaboration: recommendations for enhancing the reporting and usefulness of paediatric randomised trial protocols', BMJ (Clinical research ed.), vol. 392, e085064, pp. e085064. https://doi.org/10.1136/bmj-2025-085064

TY - JOUR

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AU - Baba, Ami

AU - Smith, Maureen

AU - Potter, Beth K

AU - Chan, An-Wen

AU - Moher, David

AU - Toulany, Alene

AU - Doherty-Kirby, Amanda

AU - Escalera, Begonya Nafria

AU - Stratton, Catherine

AU - Gale, Chris

AU - Macarthur, Colin

AU - Purper-Ouakil, Diane

AU - Juszczak, Edmund

AU - Cohen, Eyal

AU - Reggiardo, Giorgio

AU - Preston, Jennifer

AU - Cohen, Jérémie F

AU - Upton, Julia

AU - Allegaert, Karel

AU - Boerner, Katelynn

AU - Mehta, Kayur

AU - Nguyen, Kim An

AU - Courtney, Kimberly

AU - Hartling, Lisa

AU - Konstantinidis, Menelaos

AU - Odermarsky, Michal

AU - Butcher, Nancy J

AU - Kolehmainen, Niina

AU - Longmuir, Patricia E

AU - Gill, Peter J

AU - Leroy, Piet

AU - Feneberg, Reinhard

AU - Poluru, Ramesh

AU - Morris, Shaun K

AU - Friedrichsdorf, Stefan J

AU - Nagy, Tanya Chute

AU - Klassen, Terry P

AU - Lacaze-Masmonteil, Thierry

AU - Onland, Wes

AU - Offringa, Martin

PY - 2026/2/24

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DO - 10.1136/bmj-2025-085064

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SN - 0959-8146

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