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References
Simões EAF, Center KJ, Tita ATN, Swanson KA, Radley D, Houghton J, et al. Prefusion F protein-based respiratory syncytial virus immunization in pregnancy. N Engl J Med. 2022;386:1615–26.
US Food and Drug Administration. Synagis; 2021. p. 1–15.
American Academy of Pediatrics Committee on Infectious Diseases; American Academy of Pediatrics Bronchiolitis Guidelines Committee. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics. 2014;134:e620–38.
O’Brien KL, Chandran A, Weatherholtz R, Jafri HS, Griffin MP, Bellamy T, et al. Efficacy of motavizumab for the prevention of respiratory syncytial virus disease in healthy native American infants: a phase 3 randomized double-blind placebo-controlled trial. Lancet Infect Dis. 2015;15:1398–408.
Shahabi A, Peneva D, Incerti D, McLaurin K, Stevens W. Assessing variation in the cost of palivizumab for respiratory syncytial virus prevention in preterm infants. Pharmacoecon Open. 2018;2:53–61.
Kim HW, Canchola JG, Brandt CD, Pyles G, Chanock RM, Jensen K, et al. Respiratory syncytial virus disease in infants despite prior administration of antigenic inactivated vaccine. Am J Epidemiol. 1969;89:422–34.
Mejias A, Garcia-Maurino C, Rodriguez-Fernandez R, Peeples ME, Ramilo O. Development and clinical applications of novel antibodies for prevention and treatment of respiratory syncytial virus infection. Vaccine. 2017;35:496–502.
Kampmann B, Madhi SA, Munjal I, Simões EAF, Pahud BA, Llapur C, et al. Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants. N Engl J Med. 2023;388:1451–64.
Riffenburgh RH. Managing results of analysis. In: Statistics in Medicine, 3rd edition. San Diego, CA, USA: Academic Press; 2012. p. 325–43.
Jennison C, Turnbull BW. Statistical approaches to interim monitoring of medical trials: a review and commentary. Stat Sci. 1990;5:299–317.
Kumar A, Chakraborty BS. Interim analysis: a rational approach of decision making in clinical trial. J Adv Pharm Technol Res. 2016;7:118–22.
Tyson JE, Pedroza C, Wallace D, D’Angio C, Bell EF, Das A. Stopping guidelines for an effectiveness trial: what should the protocol specify? Trials. 2016;17:240.
Guyatt GH, Briel M, Glasziou P, Bassler D, Montori VM. Problems of stopping trials early. BMJ Br Med J. 2012;344:e3863.
Bassler D, Montori VM, Briel M, Glasziou P, Guyatt G. Early stopping of randomized clinical trials for overt efficacy is problematic. J Clin Epidemiol. 2008;61:241–6.
Lewis RJ. An introduction to the use of interim data analyses in clinical trials. Ann Emerg Med. 1993;22:1463–9.
Fisher JG, Jones BA, Gutierrez IM, Hull MA, Kang KH, Kenny M, et al. Mortality associated with laparotomy-confirmed neonatal spontaneous intestinal perforation: a prospective 5-year multicenter analysis. J Pediatr Surg. 2014;49:1215–9.
Chen D-T, Schell MJ, Fulp WJ, Pettersson F, Kim S, Gray JE, et al. Application of Bayesian predictive probability for interim futility analysis in single-arm phase II trial. Transl Cancer Res. 2019;8:S404–20.
Pedroza C, Tyson JE, Das A, Laptook A, Bell EF, Shankaran S. Advantages of Bayesian monitoring methods in deciding whether and when to stop a clinical trial: an example of a neonatal cooling trial. Trials. 2016;17:335.
Ryan EG, Brock K, Gates S, Slade D. Do we need to adjust for interim analyses in a Bayesian adaptive trial design? BMC Med Res Methodol. 2020;20:150.
Friedman LM, Furberg CD, DeMets DL, Reboussin DM, Granger CB. Statistical methods used in interim monitoring. fundamentals of clinical trials. Springer; 2015. p. 373–401.
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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).
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ACL conceived the analysis, wrote the first draft, and finalized the paper. PJS contributed ideas in the summary of the article analyzed, and reviewed and edited the paper. JLS contributed ideas in the “Commentary” and “EBM Lesson” sections and reviewed and edited the paper. All authors reviewed and approved the final version of the manuscript.
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Lure, A.C., Sánchez, P.J. & Slaughter, J.L. Does prefusion F protein-based respiratory syncytial virus immunization in pregnancy safely promote transplacental transfer of neutralizing antibodies?. J Perinatol 44, 142–145 (2024). https://doi.org/10.1038/s41372-023-01769-3
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DOI: https://doi.org/10.1038/s41372-023-01769-3