Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Journal Club
  • Published:

Retrospective consent for neonatal intubations. Going with the flow?

This is a preview of subscription content, access via your institution

Access options

Buy this article

Prices may be subject to local taxes which are calculated during checkout

References

  1. Hatch LD 3rd, Clark RH, Carlo WA, Stark AR, Ely EW, Patrick SW. Changes in use of respiratory support for preterm infants in the US, 2008-2018. JAMA Pediatr. 2021;175:1017–24.

    Article  PubMed  Google Scholar 

  2. Weiner GM, Zaichkin J, editors. Textbook of neonatal resuscitation. American Academy of Pediatrics, 2021. https://doi.org/10.1542/9781610025256.

  3. O’Donnell CP, Kamlin CO, Davis PG, Morley CJ. Endotracheal intubation attempts during neonatal resuscitation: success rates, duration, and adverse effects. Pediatrics. 2006;117:e16–21.

    Article  PubMed  Google Scholar 

  4. Singh N, Sawyer T, Johnston LC, Herrick HM, Moussa A, Zenge J, et al. Impact of multiple intubation attempts on adverse tracheal intubation associated events in neonates: a report from the NEAR4NEOS. J Perinatol. 2022;42:1221–7.

    Article  PubMed  Google Scholar 

  5. Miller KE, Singh N. Association of multiple tracheal intubation attempts with clinical outcomes in extremely preterm infants: a retrospective single-center cohort study. J Perinatol. 2022;42:1216–20.

    Article  PubMed  Google Scholar 

  6. Patel A, Nouraei SA. Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): a physiological method of increasing apnoea time in patients with difficult airways. Anaesthesia. 2015;70:323–9.

    Article  CAS  PubMed  Google Scholar 

  7. Humphreys S, Lee-Archer P, Reyne G, Long D, Williams T, Schibler A. Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) in children: a randomized controlled trial. Br J Anaesth. 2017;118:232–8.

    Article  CAS  PubMed  Google Scholar 

  8. Organization for Economic Cooperation and Development. OECD health statistics. 2015. http://stats.oecd.org/index.aspx?DataSetCode=HEALTH_STAT. Accessed 4 December 2023.

  9. Hodgson KA, Davis PG, Owen LS. Nasal high flow therapy for neonates: current evidence and future directions. J Paediatr Child Health. 2019;55:285–90.

    Article  PubMed  Google Scholar 

  10. World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310:2191–4.

  11. Songstad NT, Roberts CT, Manley BJ, Owen LS, Davis PG. Retrospective consent in a neonatal randomized controlled trial. Pediatrics. 2018;141:e20172092.

  12. U.S. Department of Health and Human Services Food and Drug Administration. IRB waiver or alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects guidance for sponsors, investigators, and institutional review boards. 2017. fda.gov.

  13. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada and Social Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2. Chapter 3: The Consent Process. 2022. ethics.gc.ca.

  14. Department of Health. Mental Capacity Act. 2005. https://www.legislation.gov.uk/ukpga/2005/9/pdfs/ukpga_20050009_en.pdf2005.

  15. European Union. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing directive 2001/20/EC. European Union. 2014.

  16. Schmidt B, Gillie P, Caco C, Roberts J, Roberts R. Do sick newborn infants benefit from participation in a randomized clinical trial?. J Pediatr. 1999;134:151–5.

    Article  CAS  PubMed  Google Scholar 

  17. Krishna S, Fuloria M. Ethical considerations in neonatal research. Neoreviews. 2022;23:e151–e8.

    Article  PubMed  Google Scholar 

  18. Vohra S, Reilly M, Rac VE, Bhaloo Z, Zayak D, Wimmer J, et al. Differences in demographics and outcomes based on method of consent for a randomised controlled trial on heat loss prevention in the delivery room. Arch Dis Child Fetal neonatal Ed. 2021;106:118–24.

    Article  PubMed  Google Scholar 

  19. Rich W, Finer NN, Gantz MG, Newman NS, Hensman AM, Hale EC, et al. Enrollment of extremely low birth weight infants in a clinical research study may not be representative. Pediatrics. 2012;129:480–4.

    Article  PubMed  PubMed Central  Google Scholar 

  20. Katheria A, Reister F, Essers J, Mendler M, Hummler H, Subramaniam A, et al. Association of umbilical cord milking vs delayed umbilical cord clamping with death or severe intraventricular hemorrhage among preterm infants. JAMA. 2019;322:1877–86.

    Article  PubMed  PubMed Central  Google Scholar 

  21. Vohra S, Roberts RS, Zhang B, Janes M, Schmidt B. Heat Loss Prevention (HeLP) in the delivery room: a randomized controlled trial of polyethylene occlusive skin wrapping in very preterm infants. J Pediatr. 2004;145:750–3.

    Article  PubMed  Google Scholar 

Download references

Acknowledgements

The Journal Club is a collaboration between the American Academy of Pediatrics – Section of Neonatal Perinatal Medicine and the International Society of Evidence-Based Neonatology (EBNEO.org).

Author information

Authors and Affiliations

Authors

Contributions

Both authors listed contributed equally to this work.

Corresponding author

Correspondence to Erica Andrews McArthur.

Ethics declarations

Competing interests

The authors declare no competing interests.

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Andrews McArthur, E., Saroha, V. Retrospective consent for neonatal intubations. Going with the flow?. J Perinatol 43, 1330–1333 (2023). https://doi.org/10.1038/s41372-023-01758-6

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/s41372-023-01758-6

Search

Quick links