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Paediatrics
Research
Cross-sectional analysis on publication status and age representation of clinical studies addressing mechanical ventilation and ventilator-induced lung injury in infants and children
  1. Christian Patry1,2,
  2. Simon Kranig3,
  3. Neysan Rafat4,
  4. Thomas Schaible4,
  5. Burkhard Toenshoff1,
  6. Georg F Hoffmann1,
  7. Markus Ries5
  1. 1 Department of Pediatrics I, University Children’s Hospital Heidelberg, Heidelberg, Germany
  2. 2 Institute for Physiology and Pathophysiology, University Children’s Hospital Heidelberg, Heidelberg, Germany
  3. 3 Department of Neonatology, University Children’s Hospital Heidelberg, Heidelberg, Germany
  4. 4 Clinic for Neonatology, University Medical Center Mannheim, Mannheim, Germany
  5. 5 Pediatric Neurology and Metabolic Medicine, Center for Pediatric and Adolescent Medicine, University Hospital Heidelberg, Heidelberg, Germany
  1. Correspondence to Dr Christian Patry; christian.patry{at}med.uni-heidelberg.de

Abstract

Objectives We determined the number and time-to-public availability of study results of published and unpublished clinical studies in paediatric mechanical ventilation (MV) and ventilator-induced lung injury (VILI), which were registered as completed on ClinicalTrials.gov. Furthermore, we explored the pattern of represented research study subtopics and the corresponding study populations.

Setting Literature search based on ClinicalTrials.gov, PubMed and Google Scholar from 9 July 2017 to 27 September 2017.

Primary and secondary outcome measures Assessment, if studies included in our analysis had been published. Assessment of primary research focus, patient enrolment and age representation of the analysed studies.

Results We identified n=109 registered and completed clinical studies on paediatric MV and VILI (enrolment: 22 233 participants). 71% were published, including data from 18 647 subjects. 29% of studies were unpublished, containing data from 3586 subjects. Median time-to-public availability of study results was 22 (IQR, 12.8–41.5) months. The most important study subtopics were biophysical and technical aspects of MV (32 studies), administration of drugs to mitigate VILI through various mechanisms (40 studies) and diagnostic procedures (16 studies). n=66/109 (61%) studies exclusively focused on children below 1 year of age and n=2/109 (2%) exclusively on children between 1 and 14 years.

Conclusions One-third of clinical studies in paediatric MV and VILI registered as completed on ClinicalTrials.gov remained unpublished and contained data on 3586 study participants. The overall median time-to-public availability of study results was longer than the deadline of 12 months mandated by the Food and Drug Administration Amendment Act of 2007. Important and clinically relevant research study subtopics were represented in the research questions investigated in paediatric MV and VILI. The study population was skewed towards children younger than 1 year which indicates, that there is a substantial need for clinical VILI research in older children.

  • publication bias
  • research ethics
  • evidence-based medicine
  • mechanical ventilation
  • ventilator induced lung injury
  • pediatrics

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-023524

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    Footnotes

    • CP and SK contributed equally.

    • Contributors CP designed and performed research, analysed the data and wrote the manuscript. SK performed research and analysed the data. CP and SK contributed equally to this work. NR and TS analysed the data. BT and GFH designed research and revised the manuscript. MR designed research, analysed the data and revised the manuscript.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Patient consent Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement All data generated or analysed during this study are included in this published article and its online supplementary files. The respective clinical studies analysed in this study can be accessed via ClinicalTrials.gov. Search criteria were given in the methods section of this manuscript.