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When perfection is the enemy of good: EBM lessons from the HIP trial

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Fig. 1: The Enrollment Theorem.

References

  1. Dempsey EM, Barrington KJ, Marlow N, O’Donnell CPF, Miletin J, Naulaers G, et al. Hypotension in Preterm Infants (HIP) randomised trial. Arch Dis Child: Fetal Neonatal Ed. 2021;106:F398–403.

    Article  Google Scholar 

  2. Garvey AA, Kooi EMW, Dempsey EM. Inotropes for preterm infants: 50 years on are we any wiser? Front Pediatr. 2018;6:88.

  3. Stranak Z, Semberova J, Barrington K, O’Donnell C, Marlow N, Naulaers G, et al. International survey on diagnosis and management of hypotension in extremely preterm babies. Eur J Pediatr. 2014;173:793–8.

    Article  PubMed  PubMed Central  Google Scholar 

  4. Faust K, Härtel C, Preuß M, Rabe H, Roll C, Emeis M, et al. Short-term outcome of very-low-birthweight infants with arterial hypotension in the first 24 h of life. Arch Dis Child: Fetal Neonatal Ed. 2015;100:F388–92.

    Article  Google Scholar 

  5. Da O, Paradisis M, Nj E. The effect of inotropes on morbidity and mortality in preterm infants with low systemic or organ blood flow (Review) [Internet]. 2010. http://www.thecochranelibrary.com

  6. Watterberg KL, Fernandez E, Walsh MC, Truog WE, Stoll BJ, Sokol GM, et al. Barriers to enrollment in a randomized controlled trial of hydrocortisone for cardiovascular insufficiency in term and late preterm newborn infants. J Perinatol. 2017;37:1220–3.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  7. Batton BJ, Li L, Newman NS, Das A, Watterberg KL, Yoder BA, et al. Feasibility study of early blood pressure management in extremely preterm infants. J Pediatr. 2012;161:65-9.

  8. Warshaw MG, Carey VJ, McFarland EJ, Dawson L, Abrams E, Melvin A, et al. The interaction between equipoise and logistics in clinical trials: a case study. Clin Trials. 2017;14:314–8.

    Article  PubMed  PubMed Central  Google Scholar 

  9. Pocock SJ, Stone GW. The primary outcome fails—what next? N Engl J Med. 2016;375:861–70.

    Article  PubMed  Google Scholar 

  10. Wasserstein RL, Lazar NA. The ASA’s statement on p-values: context, process, and purpose. American Statistician. American Statistical Association. 2016;70:129–33.

  11. Blakely ML, Tyson JE, Lally KP, Hintz SR, Eggleston B, Stevenson DK, et al. Initial laparotomy versus peritoneal drainage in extremely low birthweight infants with surgical necrotizing enterocolitis or isolated intestinal perforation: a multicenter randomized clinical trial. Ann Surg. 2021;274:e370–80.

    PubMed  Google Scholar 

  12. Laptook AR, Shankaran S, Tyson JE, Munoz B, Bell EF, Goldberg RN, et al. Effect of therapeutic hypothermia initiated After 6 h of age on death or disability among newborns with hypoxic-ischemic encephalopathy a randomized clinical trial. JAMA [Internet]. 2017;318:1550–60. https://jamanetwork.com/

    Article  Google Scholar 

  13. Wijeysundera DN, Austin PC, Hux JE, Beattie WS, Laupacis A. Bayesian statistical inference enhances the interpretation of contemporary randomized controlled trials. J Clin Epidemiol. 2009;62:13-21.

  14. Rindskopf D. Overview of Bayesian statistics. Eval Rev. 2020;44:225–37.

    Article  PubMed  Google Scholar 

  15. D’angio CT, Chess PR, Kovacs SJ, Sinkin RA, Phelps DL, Kendig JW, et al. Pressure-regulated volume control ventilation vs synchronized intermittent mandatory ventilation for very low-birth-weight infants a randomized controlled trial. Arch Pediatr Adolesc Med. 2005;159:868–75.

    Article  PubMed  Google Scholar 

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Acknowledgements

The Journal club is a collaboration between the American Academy of Pediatrics-Section of Neonatal-Perinatal Medicine and the International Society for Evidence-based neonatology (EBNEO.org). No funding was received for this journal review.

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Both authors contributed to the concept, design, and writing of this journal review.

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Correspondence to Cara Beth Carr.

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Carr, C.B., Ryan, R.M. When perfection is the enemy of good: EBM lessons from the HIP trial. J Perinatol (2022). https://doi.org/10.1038/s41372-022-01554-8

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