AJRCCM Articles in Press. Published on 11-October-2017 as 10.1164/rccm.201708-1605LE

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Letter to the Editor: Title: Precise gestational age definitions needed for Palivizumab prophylaxis in preterm infants

Re: Palivizumab Prophylaxis in Preterm Infants and Subsequent Recurrent Wheezing. Six-Year Follow-up Study. Hiroyuki Mochizuki , Satoshi Kusuda , Kenji Okada , Shigemi Yoshihara , Hiroyuki Furuya , and Eric A. F. Simões Am J Respir Crit Care Med. 2017 Jul; 196(1):29-38. . Running Title: Exact gestational age categories for meaningful analysis

Key words: respiratory syncytial virus (RSV), Palivizumab prophylaxis, gestational age, preterm infants Word count: 376 Conception and design:Dr Chabra; Analysis and interpretation: Dr Chabra Conflict of Interest: None Source of Funding: None Corresponding Author:

Shilpi Chabra, MD University of Washington Department of Pediatrics, Division of Neonatology 1959 NE Pacific St., Box 356320 Seattle, WA 98195 (P) 206-221-6398 (F) 206-543-8926 Email: [email protected]

Copyright © 2017 by the American Thoracic Society

AJRCCM Articles in Press. Published on 11-October-2017 as 10.1164/rccm.201708-1605LE

Precise gestational age definitions needed for palivizumab prophylaxis in preterm infants I read the interesting multicenter prospective observational study1 in preterm infants evaluating the impact of palivizumab prophylaxis on subsequent recurrent wheezing and atopic asthma. The authors of this case-control study followed children (those treated with palivizumab and those not treated) for 6 years and concluded that palivizumab administered to preterm infants 33-35 weeks gestational age (GA) did not suppress the onset of atopic asthma but resulted in a significantly lower incidence of recurrent wheezing during the first 6 years.

Interestingly, in the study design, inclusion criteria for preterm infants 33 to 35 weeks GA is not defined; hence it is not clear whether they include infants born at 33 weeks, 0 days through 35 weeks, 6 days GA or those born at 33 weeks, 0 days through 34 weeks, 6 days GA. It is important to include the exact definition of GA categories in the methods for accurate interpretation of the study results and clinical application in long term outcomes such as asthma and wheezing.

The American Academy of Pediatrics (AAP) definition of gestational age that has been used in the Committee on Infectious Diseases (COID) documents for palivizumab prophylaxis is that 33 to 35 weeks’ GA is defined as 33 weeks 0 days through 34 weeks 6 days2. However, variations in definitions used for GA categories of preterm infants in other studies3,4 add to further difficulty with interpretation of the results of palivizumab prophylaxis. Appropriate evaluation of longterm respiratory outcome studies after palivizumab prophylaxis is especially important for medical vigilance because since 2014, AAP does not recommend palivizumab prophylaxis for healthy infants born at or after 29 weeks, 0 days’ gestation.5

Copyright © 2017 by the American Thoracic Society

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AJRCCM Articles in Press. Published on 11-October-2017 as 10.1164/rccm.201708-1605LE

The authors also report this study to be a continuous investigation of late preterm infants (LPT) recruited in the Committee on Recurrent Wheezing study. This can also be confusing as LPT6 infants are defined by AAP as infants born between 34 0/7 and 36 0/7 wks GA, however this study included 33 week infants, which do not belong to the LPT category of preterm infants.

This letter calls for use of precise definitions for GA categories of preterm infants receiving palivizumab prophylaxis, which is vital to meaningful analysis of future studies as respiratory syncytial virus disease continues to be a significant public health concern.

Copyright © 2017 by the American Thoracic Society

AJRCCM Articles in Press. Published on 11-October-2017 as 10.1164/rccm.201708-1605LE

References 1. Hiroyuki Mochizuki , Satoshi Kusuda , Kenji Okada , Shigemi Yoshihara , Hiroyuki Furuya , and Eric A. F. Simões. Palivizumab Prophylaxis in Preterm Infants and Subsequent Recurrent Wheezing. Six-Year Follow-up Study. Am J Respir Crit Care Med. 2017 Jul; 196(1):29-38 2. American Academy of Pediatrics Committee on Infectious Diseases. Policy statementsmodified recommendations for use of palivizumab for prevention of respiratory syncytial virus infections. Pediatrics 2009;124(6):1694–1701 3. Anderson EJ, Krilov LR, DeVincenzo JP et al. SENTINEL1:An Observational Study of Respiratory Syncytial Virus Hospitalizations among U.S. Infants Born at 29 to 35 Weeks’ Gestational Age Not Receiving Immunoprophylaxis. Am J Perinatol. 2017;34:51–61 4. Sheridan-Pereira M, Murphy J, Sloan J et al. Respiratory Syncytial Virus Preterm (32–36 Completed Weeks of Gestation) Risk Estimation Measure for RSV Hospitalization in Ireland. The Pediatric Infectious Disease Journal 2016. 35 (1):19-24. 5. American Academy of Pediatrics Committee on Infectious Diseases and 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(2):415–420 6. Raju TN. Epidemiology of late preterm (near-term) births. Clinics in Perinatology 2006, 33(4), 751-763.

Copyright © 2017 by the American Thoracic Society

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Precise Gestational Age Definitions Needed for Palivizumab Prophylaxis in Preterm Infants.

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