Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection

Michael T. Brady; Carrie L. Byington; H. Dele Davies; Kathryn M. Edwards; Mary Anne Jackson; Yvonne A. Maldonado; Dennis L Murray; Walter A. Orenstein; Mobeen H. Rathore; Mark H. Sawyer; Gordon E. Schutze; Rodney E. Willoughby; Theoklis E. Zaoutis; Henry H. Bernstein; David W. Kimberlin; Sarah S. Long; H. Cody Meissner; Marc A. Fischer; Bruce G. Gellin; Richard L. Gorman; Lucia H. Lee; R. Douglas Pratt; Jennifer S. Read; Joan L. Robinson; Marco Aurelio Palazzi Safadi; Jane F. Seward; Jeffrey R. Starke; Geoffrey R. Simon; Tina Q. Tan; Joseph A. Bocchini; W. Robert Morrow; Larry K. Pickering; Geoffrey L. Rosenthal; Dan L. Stewart; Jennifer M. Frantz; Shawn L. Ralston; Allan S. Lieberthal; Brian K. Alverson; Jill E. Baley; Anne M. Gadomski; David W. Johnson; Michael J. Light; Nizar F. Maraqa; Eneida A. Mendonca; Kieran J. Phelan; Joseph J. Zorc; Danette Stanko-Lopp; Sinsi Hernández-Cancio; Mark A. Brown; Ian Nathanson; Elizabeth Rosenblum; Stephen Sayles; Caryn Davidson

doi:10.1542/peds.2014-1666

Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection

Michael T. Brady, Carrie L. Byington, H. Dele Davies, Kathryn M. Edwards, Mary Anne Jackson, Yvonne A. Maldonado, Dennis L Murray, Walter A. Orenstein, Mobeen H. Rathore, Mark H. Sawyer, Gordon E. Schutze, Rodney E. Willoughby, Theoklis E. Zaoutis, Henry H. Bernstein, David W. Kimberlin, Sarah S. Long, H. Cody Meissner, Marc A. Fischer, Bruce G. Gellin, Richard L. GormanLucia H. Lee, R. Douglas Pratt, Jennifer S. Read, Joan L. Robinson, Marco Aurelio Palazzi Safadi, Jane F. Seward, Jeffrey R. Starke, Geoffrey R. Simon, Tina Q. Tan, Joseph A. Bocchini, W. Robert Morrow, Larry K. Pickering, Geoffrey L. Rosenthal, Dan L. Stewart, Jennifer M. Frantz, Shawn L. Ralston, Allan S. Lieberthal, Brian K. Alverson, Jill E. Baley, Anne M. Gadomski, David W. Johnson, Michael J. Light, Nizar F. Maraqa, Eneida A. Mendonca, Kieran J. Phelan, Joseph J. Zorc, Danette Stanko-Lopp, Sinsi Hernández-Cancio, Mark A. Brown, Ian Nathanson, Elizabeth Rosenblum, Stephen Sayles, Caryn Davidson

Pediatrics

Research output: Contribution to journal › Article › peer-review

530 Scopus citations

Abstract

Guidance from the American Academy of Pediatrics (AAP) for the use of palivizumab prophylaxis against respiratory syncytial virus (RSV) was first published in a policy statement in 1998. Guidance initially was based on the result from a single randomized, placebo-controlled clinical trial conducted in 1996-1997 describing an overall reduction in RSV hospitalization rate from 10.6% among placebo recipients to 4.8% among children who received prophylaxis. The results of a second randomized, placebo-controlled trial of children with hemodynamically significant heart disease were published in 2003 and revealed a reduction in RSV hospitalization rate from 9.7% in control subjects to 5.3% among prophylaxis recipients. Because no additional controlled trials regarding efficacy were published, AAP guidance has been updated periodically to reflect the most recent literature regarding children at greatest risk of severe disease. Since the last update in 2012, new data have become available regarding the seasonality of RSV circulation, palivizumab pharmacokinetics, the changing incidence of bronchiolitis hospitalizations, the effects of gestational age and other risk factors on RSV hospitalization rates, the mortality of children hospitalized with RSV infection, and the effect of prophylaxis on wheezing and palivizumab-resistant RSV isolates. These data enable further refinement of AAP guidance to most clearly focus on those children at greatest risk.

Original language	English (US)
Pages (from-to)	e620-e638
Journal	Pediatrics
Volume	134
Issue number	2
DOIs	https://doi.org/10.1542/peds.2014-1666
State	Published - Aug 1 2014

Keywords

Bronchiolitis
Chronic lung disease
Congenital heart disease
Infants and young children
Palivizumab
RSV
Respiratory syncytial virus

ASJC Scopus subject areas

Pediatrics, Perinatology, and Child Health

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10.1542/peds.2014-1666

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Brady, M. T., Byington, C. L., Davies, H. D., Edwards, K. M., Jackson, M. A., Maldonado, Y. A., Murray, D. L., Orenstein, W. A., Rathore, M. H., Sawyer, M. H., Schutze, G. E., Willoughby, R. E., Zaoutis, T. E., Bernstein, H. H., Kimberlin, D. W., Long, S. S., Meissner, H. C., Fischer, M. A., Gellin, B. G., ... Davidson, C. (2014). Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics, 134(2), e620-e638. https://doi.org/10.1542/peds.2014-1666

Brady, MT, Byington, CL, Davies, HD, Edwards, KM, Jackson, MA, Maldonado, YA, Murray, DL, Orenstein, WA, Rathore, MH, Sawyer, MH, Schutze, GE, Willoughby, RE, Zaoutis, TE, Bernstein, HH, Kimberlin, DW, Long, SS, Meissner, HC, Fischer, MA, Gellin, BG, Gorman, RL, Lee, LH, Pratt, RD, Read, JS, Robinson, JL, Safadi, MAP, Seward, JF, Starke, JR, Simon, GR, Tan, TQ, Bocchini, JA, Morrow, WR, Pickering, LK, Rosenthal, GL, Stewart, DL, Frantz, JM, Ralston, SL, Lieberthal, AS, Alverson, BK, Baley, JE, Gadomski, AM, Johnson, DW, Light, MJ, Maraqa, NF, Mendonca, EA, Phelan, KJ, Zorc, JJ, Stanko-Lopp, D, Hernández-Cancio, S, Brown, MA, Nathanson, I, Rosenblum, E, Sayles, S & Davidson, C 2014, 'Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection', Pediatrics, vol. 134, no. 2, pp. e620-e638. https://doi.org/10.1542/peds.2014-1666

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title = "Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection",

abstract = "Guidance from the American Academy of Pediatrics (AAP) for the use of palivizumab prophylaxis against respiratory syncytial virus (RSV) was first published in a policy statement in 1998. Guidance initially was based on the result from a single randomized, placebo-controlled clinical trial conducted in 1996-1997 describing an overall reduction in RSV hospitalization rate from 10.6% among placebo recipients to 4.8% among children who received prophylaxis. The results of a second randomized, placebo-controlled trial of children with hemodynamically significant heart disease were published in 2003 and revealed a reduction in RSV hospitalization rate from 9.7% in control subjects to 5.3% among prophylaxis recipients. Because no additional controlled trials regarding efficacy were published, AAP guidance has been updated periodically to reflect the most recent literature regarding children at greatest risk of severe disease. Since the last update in 2012, new data have become available regarding the seasonality of RSV circulation, palivizumab pharmacokinetics, the changing incidence of bronchiolitis hospitalizations, the effects of gestational age and other risk factors on RSV hospitalization rates, the mortality of children hospitalized with RSV infection, and the effect of prophylaxis on wheezing and palivizumab-resistant RSV isolates. These data enable further refinement of AAP guidance to most clearly focus on those children at greatest risk.",

keywords = "Bronchiolitis, Chronic lung disease, Congenital heart disease, Infants and young children, Palivizumab, RSV, Respiratory syncytial virus",

author = "Brady, {Michael T.} and Byington, {Carrie L.} and Davies, {H. Dele} and Edwards, {Kathryn M.} and Jackson, {Mary Anne} and Maldonado, {Yvonne A.} and Murray, {Dennis L} and Orenstein, {Walter A.} and Rathore, {Mobeen H.} and Sawyer, {Mark H.} and Schutze, {Gordon E.} and Willoughby, {Rodney E.} and Zaoutis, {Theoklis E.} and Bernstein, {Henry H.} and Kimberlin, {David W.} and Long, {Sarah S.} and Meissner, {H. Cody} and Fischer, {Marc A.} and Gellin, {Bruce G.} and Gorman, {Richard L.} and Lee, {Lucia H.} and Pratt, {R. Douglas} and Read, {Jennifer S.} and Robinson, {Joan L.} and Safadi, {Marco Aurelio Palazzi} and Seward, {Jane F.} and Starke, {Jeffrey R.} and Simon, {Geoffrey R.} and Tan, {Tina Q.} and Bocchini, {Joseph A.} and Morrow, {W. Robert} and Pickering, {Larry K.} and Rosenthal, {Geoffrey L.} and Stewart, {Dan L.} and Frantz, {Jennifer M.} and Ralston, {Shawn L.} and Lieberthal, {Allan S.} and Alverson, {Brian K.} and Baley, {Jill E.} and Gadomski, {Anne M.} and Johnson, {David W.} and Light, {Michael J.} and Maraqa, {Nizar F.} and Mendonca, {Eneida A.} and Phelan, {Kieran J.} and Zorc, {Joseph J.} and Danette Stanko-Lopp and Sinsi Hern{\'a}ndez-Cancio and Brown, {Mark A.} and Ian Nathanson and Elizabeth Rosenblum and Stephen Sayles and Caryn Davidson",

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AU - Byington, Carrie L.

AU - Davies, H. Dele

AU - Edwards, Kathryn M.

AU - Jackson, Mary Anne

AU - Maldonado, Yvonne A.

AU - Murray, Dennis L

AU - Orenstein, Walter A.

AU - Rathore, Mobeen H.

AU - Sawyer, Mark H.

AU - Schutze, Gordon E.

AU - Willoughby, Rodney E.

AU - Zaoutis, Theoklis E.

AU - Bernstein, Henry H.

AU - Kimberlin, David W.

AU - Long, Sarah S.

AU - Meissner, H. Cody

AU - Fischer, Marc A.

AU - Gellin, Bruce G.

AU - Gorman, Richard L.

AU - Lee, Lucia H.

AU - Pratt, R. Douglas

AU - Read, Jennifer S.

AU - Robinson, Joan L.

AU - Safadi, Marco Aurelio Palazzi

AU - Seward, Jane F.

AU - Starke, Jeffrey R.

AU - Simon, Geoffrey R.

AU - Tan, Tina Q.

AU - Bocchini, Joseph A.

AU - Morrow, W. Robert

AU - Pickering, Larry K.

AU - Rosenthal, Geoffrey L.

AU - Stewart, Dan L.

AU - Frantz, Jennifer M.

AU - Ralston, Shawn L.

AU - Lieberthal, Allan S.

AU - Alverson, Brian K.

AU - Baley, Jill E.

AU - Gadomski, Anne M.

AU - Johnson, David W.

AU - Light, Michael J.

AU - Maraqa, Nizar F.

AU - Mendonca, Eneida A.

AU - Phelan, Kieran J.

AU - Zorc, Joseph J.

AU - Stanko-Lopp, Danette

AU - Hernández-Cancio, Sinsi

AU - Brown, Mark A.

AU - Nathanson, Ian

AU - Rosenblum, Elizabeth

AU - Sayles, Stephen

AU - Davidson, Caryn

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KW - Respiratory syncytial virus

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Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection

Abstract

Keywords

ASJC Scopus subject areas

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