COSMIC: a core outcome set for intravenous maintenance fluid therapy trials in children.

Brossier, DW ORCID: 0000-0002-2059-9888, Valla, FV, Briassoulis, G, Jotterand Chaparro, C, Chiusolo, F, Dursun, O, Duval, EL, Horvath, K, Ilia, S, Kenderessy, P, Kneyber, MCJ, Lopez, J, López-Herce, J, Mayberry, HF, Mierzewska-Schmidt, M, Miñambres Rodríguez, M, Morice, C, Moullet, C, Nallet-Amate, M, Nyandat, J et al (2026) COSMIC: a core outcome set for intravenous maintenance fluid therapy trials in children. World Journal of Pediatrics. pp. 1-14. ISSN 1708-8569

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Abstract

Background
Intravenous maintenance fluid therapy is one of the most common therapies for hospitalized children, yet the field lacks standardized outcomes to evaluate its effectiveness. Although intravenous maintenance fluid therapy has been used for nearly two centuries, existing studies show wide heterogeneity in reported endpoints, limiting the ability to perform meta-analyses and generate robust evidence. No core outcome set specific to pediatric intravenous maintenance fluid therapy currently exists, and previous initiatives have focused narrowly on fluid accumulation rather than the five components of intravenous maintenance fluid therapy prescription. This study aimed to create a comprehensive core outcome set—COSMIC—to standardize outcome reporting across research involving indications, tonicity, balanced solutions, composition, and volume of intravenous maintenance fluid therapy in children.

Methods
The study followed the core outcome measures in effectiveness trials and core outcome set–standards for development guidelines and was prospectively registered. Four phases were undertaken: a systematic literature review (1960–2023), the extraction and classification of all reported intravenous maintenance fluid therapy-related outcomes, a two-round modified Delphi process involving international experts and non-experts, and two online consensus meetings to finalize the cost. Eligible participants included authors of intravenous maintenance fluid therapy publications and healthcare professionals. Outcomes were rated on a 9-point Likert scale, and predefined consensus thresholds determined inclusion or exclusion. Items without consensus were discussed and voted on during the final meetings.

Results
The literature review identified 259 outcomes, of which 104 unique items entered Delphi round 1. Ninety participants completed round 1 and 82 round 2. Participants represented all continents. Four outcomes were deemed essential for all five PICO-based intravenous maintenance fluid therapy questions: 28-day mortality, survival free of organ dysfunction, hospital length of stay, and natremia. Additional outcomes were defined specifically for each of the five intravenous maintenance fluid therapy components, resulting in a structured and globally applicable core outcome set.

Conclusions
COSMIC is the first comprehensive core outcome set to address all core questions related to pediatric intravenous maintenance fluid therapy. It covers the full spectrum of prescription components and includes outcomes feasible across diverse healthcare settings. COSMIC adheres to the standards and provides a practical, internationally relevant framework. Its adoption will harmonize reporting, strengthen future trials, and support meta-analyses, ultimately improving evidence-based intravenous maintenance fluid therapy in children.

Item Type:	Article
Uncontrolled Keywords:	COSMIC Study Group; Metabolism Endocrinology and Nutrition Section of the European Society of Pediatric and Neonatal Intensive Care (ESPNIC), the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI), the Australian and New Zealand Intensive Care Society (ANZICS) Paediatric Study Group, the Pediatric Acute and Critical Care Medicine Asian Network (PACCMAN) and the Latin American Pediatric Intensive Care Society (SLACIP); Critical care; Fluid therapy; Health Care; Intravenous; Outcome assessment; Pediatrics; 32 Biomedical and Clinical Sciences; 3202 Clinical Sciences; Comparative Effectiveness Research; Patient Safety; Clinical Trials and Supportive Activities; Pediatric Research Initiative; Clinical Research; 3 Good Health and Well Being; 1114 Paediatrics and Reproductive Medicine; 3213 Paediatrics
Subjects:	R Medicine > RJ Pediatrics R Medicine > RT Nursing
Divisions:	Nursing, Public and Allied Health
Publisher:	Springer
Date of acceptance:	27 May 2026
Date of first compliant Open Access:	27 August 2026
Date Deposited:	27 Aug 2026 11:49
Last Modified:	27 Aug 2026 11:49
DOI or ID number:	10.1007/s12519-026-01066-x
URI:	https://researchonline.ljmu.ac.uk/id/eprint/29205

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