Treatment of neonatal sepsis with intravenous immune globulin

Peter Brocklehurst; B Farrell; A King; E Juszczak; B Darlow; K Haque; Alison Salt; Ben Stenson; William Tarnow-Mordi; S Brearley; A Leslie; J Stephenson; D Ashby; F Cockburn; A Grant; B McClelland; Neil Modi; H Thornton; D Altman; R Cooke; S Dobson; B Greene; G Greisen; T Neal; F Pradhan; B Walden; R Williams; N Armstrong; S Ayers; P Baker; U Bowler; B Catterall; V Cavendish; C Chan-Fook; M Duxbury; D Evans; S Gates; D Hawcutt; M Logan; H McElroy; P Mohan; E Morgan-Jones; J Notman; M Redshaw; C Shakeshaft; C Stevens; S Williams; R Zhao; W Hague; D Henderson-Smart; David Isaacs; John Simes; L Sebastian; R Barsenbach; J Blanco; C Brown; A Cust; P Duggal-Berri; V Gebski; M Hay; L O'Regan; A Pillai; K Mann; A Martin; S Sitha; C van Host Pellekaan; E Abalos; B Carroli; G Carroli; R Rizzi; Y Sguassero; R Garcia; A Raineri; O Falco; F Redondo; M Farri; S Funes; C Burgaretta; L Ramirez; F Fernandez; L Levinson; E Agudo; M Bisbal; M Guerrero; E Szyld; G Brazda; C Deguer; J Ceriani Cernadas; V Cravedi; A Leyton; A Prado; D Rodrigue; N Herrera; M Murad; J Aguirre; S Arosio; C Picon; N Posse; S Rolon; P Vacou; C Buking; C Soto Conti; M Deckert; M Kronemberger; I Navarro; M Turturici; E Collino; A Peyrano; N Bouceau; M Bruni; L Parga; D Varela; P Sachetti; M Alem; H Camusso; A Oviedo; P Ponce de Leon; Rafael Diaz; J Morante; G Puig; M del Barco; M Filtrin; F Oliveira; E Halac; G Alberto; S Meskell; G Reynolds; P Craven; L Hobson; K Meredith; C Chambers; J Phelps; Scott Morris; J Buchan; R Glover; J Sarunac; R Guaran; N Pazanin; J Stack; D Casalaz; S Saker; D Wilson; M Hayes; H Kopp; T Lewis; H Coughtrey; K Davies; L Simeon; D Cartwright; G Hermann; M Pritchard; John Mills; L Perkins; C Plover; K Butterley; Peter Dargaville; G Ryan; I Graudins; K Lui; J Michalowski; M Gibson; M Jeffrey; M Klucklow; N Evans; J Hay; S Reid; K Callanan; L Doyle; S Wong; P Fa; M Luig; B Twible; V Bhatia; Louise Goodchild; K Western; V Cossey; M Dahl; J Reinholdt; B Hoest; L Vad Pedersen; H Dellagrammaticas; N Iacovidou; L Bradfield; B Murphy; C Ryan; M Gojic; B Vasiljevic; N McNeill; D Pugh-Williams; R Broadbent; F McCaffrey; O Johnson; T Bushell; J L'Anson; M Wong; Malcolm Battin; K Anderson-Hawke; A Kennedy; J Brown; P Kumar; S Butler; A Hale; D Harris; D Elder; M Gibson; S Bali; A Cubitt; L Jones; O Rackham; E Macrae; J Staines; S Konig; E Wong; F Marshall; M Saeed; C Maybor; S Rose; S Chatfield; S Szpara; L Elliott; T Soe; J Nycyk; M Perry; D Freeman; D Rogahn; H Kirby; J Madar; P Adiotomre; J Watkinson; N Al Hilaly; V Wijetunge; J Simpson; R Wakefield; S Ainsworth; K McCormack; M Peters; H Tighe; M Cruwys; M Hoong; E Crosbie; A Knapton; M Lal; B Whalley; H Pentelow; P Rao; H Doyle; P Sivakumar; J Chang; S Lam; B Jani; G West; D Kirby; B Kumararatne; V Gopinathan; D Irving; S Hendry; M Ibrahim; A McGahon; R Nicholl; C Campbell; J Dorling; R Cousins; H Kisat; R Rao; D Sheehy; J Brazier; R Thambapillai; A Powls; S Provan; P Fox; S Rubin; W Barry; L Handley; J Henwood; E Murdoch; R Bhadoria; C Shoilan; M Lama; S Shahili; K Afshar; M Yadav; P Munyard; P Nichols; A Collinson; H Mill; I Al-Muzaffar; M Fernandez; J McCormick; K McCullagh; D Sweet; S Deshpande; M Taplin; L Barrow; C Lawn; J Cousins; A Pike; R Shephard; C Speirs; A Emmerson; J Mercy; C Groves; A Jain; C Waite; T Otunla; M Woodford; R Arya; M Qasim; S Sivashankar; S Armstrong; R Coombs; D Garvie; S Holmes; A Gupta; J Bradshaw; P Satodia; A Glennard; R Webb; J Frost; N Wilson; D Long; S O'Brien; S Ibhanesebhor; A McManus; A Garg; G Triance; J Blades; M Russell-Taylor; L Bowden; R O'Brien

doi:10.1056/NEJMoa1100441

Treatment of neonatal sepsis with intravenous immune globulin

Peter Brocklehurst, B Farrell, A King, E Juszczak, B Darlow, K Haque, Alison Salt, Ben Stenson, William Tarnow-Mordi, S Brearley, A Leslie, J Stephenson, D Ashby, F Cockburn, A Grant, B McClelland, Neil Modi, H Thornton, D Altman, R CookeS Dobson, B Greene, G Greisen, T Neal, F Pradhan, B Walden, R Williams, N Armstrong, S Ayers, P Baker, U Bowler, B Catterall, V Cavendish, C Chan-Fook, M Duxbury, D Evans, S Gates, D Hawcutt, M Logan, H McElroy, P Mohan, E Morgan-Jones, J Notman, M Redshaw, C Shakeshaft, C Stevens, S Williams, R Zhao, W Hague, D Henderson-Smart, David Isaacs, John Simes, L Sebastian, R Barsenbach, J Blanco, C Brown, A Cust, P Duggal-Berri, V Gebski, M Hay, L O'Regan, A Pillai, K Mann, A Martin, S Sitha, C van Host Pellekaan, E Abalos, B Carroli, G Carroli, R Rizzi, Y Sguassero, R Garcia, A Raineri, O Falco, F Redondo, M Farri, S Funes, C Burgaretta, L Ramirez, F Fernandez, L Levinson, E Agudo, M Bisbal, M Guerrero, E Szyld, G Brazda, C Deguer, J Ceriani Cernadas, V Cravedi, A Leyton, A Prado, D Rodrigue, N Herrera, M Murad, J Aguirre, S Arosio, C Picon, N Posse, S Rolon, P Vacou, C Buking, C Soto Conti, M Deckert, M Kronemberger, I Navarro, M Turturici, E Collino, A Peyrano, N Bouceau, M Bruni, L Parga, D Varela, P Sachetti, M Alem, H Camusso, A Oviedo, P Ponce de Leon, Rafael Diaz, J Morante, G Puig, M del Barco, M Filtrin, F Oliveira, E Halac, G Alberto, S Meskell, G Reynolds, P Craven, L Hobson, K Meredith, C Chambers, J Phelps, Scott Morris, J Buchan, R Glover, J Sarunac, R Guaran, N Pazanin, J Stack, D Casalaz, S Saker, D Wilson, M Hayes, H Kopp, T Lewis, H Coughtrey, K Davies, L Simeon, D Cartwright, G Hermann, M Pritchard, John Mills, L Perkins, C Plover, K Butterley, Peter Dargaville, G Ryan, I Graudins, K Lui, J Michalowski, M Gibson, M Jeffrey, M Klucklow, N Evans, J Hay, S Reid, K Callanan, L Doyle, S Wong, P Fa, M Luig, B Twible, V Bhatia, Louise Goodchild, K Western, V Cossey, M Dahl, J Reinholdt, B Hoest, L Vad Pedersen, H Dellagrammaticas, N Iacovidou, L Bradfield, B Murphy, C Ryan, M Gojic, B Vasiljevic, N McNeill, D Pugh-Williams, R Broadbent, F McCaffrey, O Johnson, T Bushell, J L'Anson, M Wong, Malcolm Battin, K Anderson-Hawke, A Kennedy, J Brown, P Kumar, S Butler, A Hale, D Harris, D Elder, M Gibson, S Bali, A Cubitt, L Jones, O Rackham, E Macrae, J Staines, S Konig, E Wong, F Marshall, M Saeed, C Maybor, S Rose, S Chatfield, S Szpara, L Elliott, T Soe, J Nycyk, M Perry, D Freeman, D Rogahn, H Kirby, J Madar, P Adiotomre, J Watkinson, N Al Hilaly, V Wijetunge, J Simpson, R Wakefield, S Ainsworth, K McCormack, M Peters, H Tighe, M Cruwys, M Hoong, E Crosbie, A Knapton, M Lal, B Whalley, H Pentelow, P Rao, H Doyle, P Sivakumar, J Chang, S Lam, B Jani, G West, D Kirby, B Kumararatne, V Gopinathan, D Irving, S Hendry, M Ibrahim, A McGahon, R Nicholl, C Campbell, J Dorling, R Cousins, H Kisat, R Rao, D Sheehy, J Brazier, R Thambapillai, A Powls, S Provan, P Fox, S Rubin, W Barry, L Handley, J Henwood, E Murdoch, R Bhadoria, C Shoilan, M Lama, S Shahili, K Afshar, M Yadav, P Munyard, P Nichols, A Collinson, H Mill, I Al-Muzaffar, M Fernandez, J McCormick, K McCullagh, D Sweet, S Deshpande, M Taplin, L Barrow, C Lawn, J Cousins, A Pike, R Shephard, C Speirs, A Emmerson, J Mercy, C Groves, A Jain, C Waite, T Otunla, M Woodford, R Arya, M Qasim, S Sivashankar, S Armstrong, R Coombs, D Garvie, S Holmes, A Gupta, J Bradshaw, P Satodia, A Glennard, R Webb, J Frost, N Wilson, D Long, S O'Brien, S Ibhanesebhor, A McManus, A Garg, G Triance, J Blades, M Russell-Taylor, L Bowden, R O'Brien

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

266 Citations (Scopus)

Abstract

BACKGROUND: Neonatal sepsis is a major cause of death and complications despite antibiotic treatment. Effective adjunctive treatments are needed. Newborn infants are relatively deficient in endogenous immunoglobulin. Meta-analyses of trials of intravenous immune globulin for suspected or proven neonatal sepsis suggest a reduced rate of death from any cause, but the trials have been small and have varied in quality. METHODS: At 113 hospitals in nine countries, we enrolled 3493 infants receiving antibiotics for suspected or proven serious infection and randomly assigned them to receive two infusions of either polyvalent IgG immune globulin (at a dose of 500 mg per kilogram of body weight) or matching placebo 48 hours apart. The primary outcome was death or major disability at the age of 2 years. RESULTS: There was no significant between-group difference in the rates of the primary outcome, which occurred in 686 of 1759 infants (39.0%) who received intravenous immune globulin and in 677 of 1734 infants (39.0%) who received placebo (relative risk, 1.00; 95% confidence interval, 0.92 to 1.08). Similarly, there were no significant differences in the rates of secondary outcomes, including the incidence of subsequent sepsis episodes. In follow-up of 2-year-old infants, there were no significant differences in the rates of major or nonmajor disability or of adverse events. CONCLUSIONS: Therapy with intravenous immune globulin had no effect on the outcomes of suspected or proven neonatal sepsis. (Funded by the United Kingdom Medical Research Council and others; INIS Current Controlled Trials number, ISRCTN94984750.).

Original language	English
Pages (from-to)	1201-1211
Number of pages	11
Journal	New England Journal of Medicine
Volume	365
Issue number	13
DOIs	https://doi.org/10.1056/NEJMoa1100441
Publication status	Published - 29 Sept 2011

Access to Document

10.1056/NEJMoa1100441

Cite this

Brocklehurst, P., Farrell, B., King, A., Juszczak, E., Darlow, B., Haque, K., Salt, A., Stenson, B., Tarnow-Mordi, W., Brearley, S., Leslie, A., Stephenson, J., Ashby, D., Cockburn, F., Grant, A., McClelland, B., Modi, N., Thornton, H., Altman, D., ... O'Brien, R. (2011). Treatment of neonatal sepsis with intravenous immune globulin. New England Journal of Medicine, 365(13), 1201-1211. https://doi.org/10.1056/NEJMoa1100441

@article{da3cf5516dd14dbabd34199ff7c2af32,

title = "Treatment of neonatal sepsis with intravenous immune globulin",

abstract = "BACKGROUND: Neonatal sepsis is a major cause of death and complications despite antibiotic treatment. Effective adjunctive treatments are needed. Newborn infants are relatively deficient in endogenous immunoglobulin. Meta-analyses of trials of intravenous immune globulin for suspected or proven neonatal sepsis suggest a reduced rate of death from any cause, but the trials have been small and have varied in quality. METHODS: At 113 hospitals in nine countries, we enrolled 3493 infants receiving antibiotics for suspected or proven serious infection and randomly assigned them to receive two infusions of either polyvalent IgG immune globulin (at a dose of 500 mg per kilogram of body weight) or matching placebo 48 hours apart. The primary outcome was death or major disability at the age of 2 years. RESULTS: There was no significant between-group difference in the rates of the primary outcome, which occurred in 686 of 1759 infants (39.0%) who received intravenous immune globulin and in 677 of 1734 infants (39.0%) who received placebo (relative risk, 1.00; 95% confidence interval, 0.92 to 1.08). Similarly, there were no significant differences in the rates of secondary outcomes, including the incidence of subsequent sepsis episodes. In follow-up of 2-year-old infants, there were no significant differences in the rates of major or nonmajor disability or of adverse events. CONCLUSIONS: Therapy with intravenous immune globulin had no effect on the outcomes of suspected or proven neonatal sepsis. (Funded by the United Kingdom Medical Research Council and others; INIS Current Controlled Trials number, ISRCTN94984750.).",

author = "Peter Brocklehurst and B Farrell and A King and E Juszczak and B Darlow and K Haque and Alison Salt and Ben Stenson and William Tarnow-Mordi and S Brearley and A Leslie and J Stephenson and D Ashby and F Cockburn and A Grant and B McClelland and Neil Modi and H Thornton and D Altman and R Cooke and S Dobson and B Greene and G Greisen and T Neal and F Pradhan and B Walden and R Williams and N Armstrong and S Ayers and P Baker and U Bowler and B Catterall and V Cavendish and C Chan-Fook and M Duxbury and D Evans and S Gates and D Hawcutt and M Logan and H McElroy and P Mohan and E Morgan-Jones and J Notman and M Redshaw and C Shakeshaft and C Stevens and S Williams and R Zhao and W Hague and D Henderson-Smart and David Isaacs and John Simes and L Sebastian and R Barsenbach and J Blanco and C Brown and A Cust and P Duggal-Berri and V Gebski and M Hay and L O'Regan and A Pillai and K Mann and A Martin and S Sitha and {van Host Pellekaan}, C and E Abalos and B Carroli and G Carroli and R Rizzi and Y Sguassero and R Garcia and A Raineri and O Falco and F Redondo and M Farri and S Funes and C Burgaretta and L Ramirez and F Fernandez and L Levinson and E Agudo and M Bisbal and M Guerrero and E Szyld and G Brazda and C Deguer and {Ceriani Cernadas}, J and V Cravedi and A Leyton and A Prado and D Rodrigue and N Herrera and M Murad and J Aguirre and S Arosio and C Picon and N Posse and S Rolon and P Vacou and C Buking and {Soto Conti}, C and M Deckert and M Kronemberger and I Navarro and M Turturici and E Collino and A Peyrano and N Bouceau and M Bruni and L Parga and D Varela and P Sachetti and M Alem and H Camusso and A Oviedo and {Ponce de Leon}, P and Rafael Diaz and J Morante and G Puig and {del Barco}, M and M Filtrin and F Oliveira and E Halac and G Alberto and S Meskell and G Reynolds and P Craven and L Hobson and K Meredith and C Chambers and J Phelps and Scott Morris and J Buchan and R Glover and J Sarunac and R Guaran and N Pazanin and J Stack and D Casalaz and S Saker and D Wilson and M Hayes and H Kopp and T Lewis and H Coughtrey and K Davies and L Simeon and D Cartwright and G Hermann and M Pritchard and John Mills and L Perkins and C Plover and K Butterley and Peter Dargaville and G Ryan and I Graudins and K Lui and J Michalowski and M Gibson and M Jeffrey and M Klucklow and N Evans and J Hay and S Reid and K Callanan and L Doyle and S Wong and P Fa and M Luig and B Twible and V Bhatia and Louise Goodchild and K Western and V Cossey and M Dahl and J Reinholdt and B Hoest and {Vad Pedersen}, L and H Dellagrammaticas and N Iacovidou and L Bradfield and B Murphy and C Ryan and M Gojic and B Vasiljevic and N McNeill and D Pugh-Williams and R Broadbent and F McCaffrey and O Johnson and T Bushell and J L'Anson and M Wong and Malcolm Battin and K Anderson-Hawke and A Kennedy and J Brown and P Kumar and S Butler and A Hale and D Harris and D Elder and M Gibson and S Bali and A Cubitt and L Jones and O Rackham and E Macrae and J Staines and S Konig and E Wong and F Marshall and M Saeed and C Maybor and S Rose and S Chatfield and S Szpara and L Elliott and T Soe and J Nycyk and M Perry and D Freeman and D Rogahn and H Kirby and J Madar and P Adiotomre and J Watkinson and {Al Hilaly}, N and V Wijetunge and J Simpson and R Wakefield and S Ainsworth and K McCormack and M Peters and H Tighe and M Cruwys and M Hoong and E Crosbie and A Knapton and M Lal and B Whalley and H Pentelow and P Rao and H Doyle and P Sivakumar and J Chang and S Lam and B Jani and G West and D Kirby and B Kumararatne and V Gopinathan and D Irving and S Hendry and M Ibrahim and A McGahon and R Nicholl and C Campbell and J Dorling and R Cousins and H Kisat and R Rao and D Sheehy and J Brazier and R Thambapillai and A Powls and S Provan and P Fox and S Rubin and W Barry and L Handley and J Henwood and E Murdoch and R Bhadoria and C Shoilan and M Lama and S Shahili and K Afshar and M Yadav and P Munyard and P Nichols and A Collinson and H Mill and I Al-Muzaffar and M Fernandez and J McCormick and K McCullagh and D Sweet and S Deshpande and M Taplin and L Barrow and C Lawn and J Cousins and A Pike and R Shephard and C Speirs and A Emmerson and J Mercy and C Groves and A Jain and C Waite and T Otunla and M Woodford and R Arya and M Qasim and S Sivashankar and S Armstrong and R Coombs and D Garvie and S Holmes and A Gupta and J Bradshaw and P Satodia and A Glennard and R Webb and J Frost and N Wilson and D Long and S O'Brien and S Ibhanesebhor and A McManus and A Garg and G Triance and J Blades and M Russell-Taylor and L Bowden and R O'Brien",

year = "2011",

month = sep,

day = "29",

doi = "10.1056/NEJMoa1100441",

language = "English",

volume = "365",

pages = "1201--1211",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

number = "13",

}

Brocklehurst, P, Farrell, B, King, A, Juszczak, E, Darlow, B, Haque, K, Salt, A, Stenson, B, Tarnow-Mordi, W, Brearley, S, Leslie, A, Stephenson, J, Ashby, D, Cockburn, F, Grant, A, McClelland, B, Modi, N, Thornton, H, Altman, D, Cooke, R, Dobson, S, Greene, B, Greisen, G, Neal, T, Pradhan, F, Walden, B, Williams, R, Armstrong, N, Ayers, S, Baker, P, Bowler, U, Catterall, B, Cavendish, V, Chan-Fook, C, Duxbury, M, Evans, D, Gates, S, Hawcutt, D, Logan, M, McElroy, H, Mohan, P, Morgan-Jones, E, Notman, J, Redshaw, M, Shakeshaft, C, Stevens, C, Williams, S, Zhao, R, Hague, W, Henderson-Smart, D, Isaacs, D, Simes, J, Sebastian, L, Barsenbach, R, Blanco, J, Brown, C, Cust, A, Duggal-Berri, P, Gebski, V, Hay, M, O'Regan, L, Pillai, A, Mann, K, Martin, A, Sitha, S, van Host Pellekaan, C, Abalos, E, Carroli, B, Carroli, G, Rizzi, R, Sguassero, Y, Garcia, R, Raineri, A, Falco, O, Redondo, F, Farri, M, Funes, S, Burgaretta, C, Ramirez, L, Fernandez, F, Levinson, L, Agudo, E, Bisbal, M, Guerrero, M, Szyld, E, Brazda, G, Deguer, C, Ceriani Cernadas, J, Cravedi, V, Leyton, A, Prado, A, Rodrigue, D, Herrera, N, Murad, M, Aguirre, J, Arosio, S, Picon, C, Posse, N, Rolon, S, Vacou, P, Buking, C, Soto Conti, C, Deckert, M, Kronemberger, M, Navarro, I, Turturici, M, Collino, E, Peyrano, A, Bouceau, N, Bruni, M, Parga, L, Varela, D, Sachetti, P, Alem, M, Camusso, H, Oviedo, A, Ponce de Leon, P, Diaz, R, Morante, J, Puig, G, del Barco, M, Filtrin, M, Oliveira, F, Halac, E, Alberto, G, Meskell, S, Reynolds, G, Craven, P, Hobson, L, Meredith, K, Chambers, C, Phelps, J, Morris, S, Buchan, J, Glover, R, Sarunac, J, Guaran, R, Pazanin, N, Stack, J, Casalaz, D, Saker, S, Wilson, D, Hayes, M, Kopp, H, Lewis, T, Coughtrey, H, Davies, K, Simeon, L, Cartwright, D, Hermann, G, Pritchard, M, Mills, J, Perkins, L, Plover, C, Butterley, K, Dargaville, P, Ryan, G, Graudins, I, Lui, K, Michalowski, J, Gibson, M, Jeffrey, M, Klucklow, M, Evans, N, Hay, J, Reid, S, Callanan, K, Doyle, L, Wong, S, Fa, P, Luig, M, Twible, B, Bhatia, V, Goodchild, L, Western, K, Cossey, V, Dahl, M, Reinholdt, J, Hoest, B, Vad Pedersen, L, Dellagrammaticas, H, Iacovidou, N, Bradfield, L, Murphy, B, Ryan, C, Gojic, M, Vasiljevic, B, McNeill, N, Pugh-Williams, D, Broadbent, R, McCaffrey, F, Johnson, O, Bushell, T, L'Anson, J, Wong, M, Battin, M, Anderson-Hawke, K, Kennedy, A, Brown, J, Kumar, P, Butler, S, Hale, A, Harris, D, Elder, D, Gibson, M, Bali, S, Cubitt, A, Jones, L, Rackham, O, Macrae, E, Staines, J, Konig, S, Wong, E, Marshall, F, Saeed, M, Maybor, C, Rose, S, Chatfield, S, Szpara, S, Elliott, L, Soe, T, Nycyk, J, Perry, M, Freeman, D, Rogahn, D, Kirby, H, Madar, J, Adiotomre, P, Watkinson, J, Al Hilaly, N, Wijetunge, V, Simpson, J, Wakefield, R, Ainsworth, S, McCormack, K, Peters, M, Tighe, H, Cruwys, M, Hoong, M, Crosbie, E, Knapton, A, Lal, M, Whalley, B, Pentelow, H, Rao, P, Doyle, H, Sivakumar, P, Chang, J, Lam, S, Jani, B, West, G, Kirby, D, Kumararatne, B, Gopinathan, V, Irving, D, Hendry, S, Ibrahim, M, McGahon, A, Nicholl, R, Campbell, C, Dorling, J, Cousins, R, Kisat, H, Rao, R, Sheehy, D, Brazier, J, Thambapillai, R, Powls, A, Provan, S, Fox, P, Rubin, S, Barry, W, Handley, L, Henwood, J, Murdoch, E, Bhadoria, R, Shoilan, C, Lama, M, Shahili, S, Afshar, K, Yadav, M, Munyard, P, Nichols, P, Collinson, A, Mill, H, Al-Muzaffar, I, Fernandez, M, McCormick, J, McCullagh, K, Sweet, D, Deshpande, S, Taplin, M, Barrow, L, Lawn, C, Cousins, J, Pike, A, Shephard, R, Speirs, C, Emmerson, A, Mercy, J, Groves, C, Jain, A, Waite, C, Otunla, T, Woodford, M, Arya, R, Qasim, M, Sivashankar, S, Armstrong, S, Coombs, R, Garvie, D, Holmes, S, Gupta, A, Bradshaw, J, Satodia, P, Glennard, A, Webb, R, Frost, J, Wilson, N, Long, D, O'Brien, S, Ibhanesebhor, S, McManus, A, Garg, A, Triance, G, Blades, J, Russell-Taylor, M, Bowden, L & O'Brien, R 2011, 'Treatment of neonatal sepsis with intravenous immune globulin', New England Journal of Medicine, vol. 365, no. 13, pp. 1201-1211. https://doi.org/10.1056/NEJMoa1100441

TY - JOUR

T1 - Treatment of neonatal sepsis with intravenous immune globulin

AU - Brocklehurst, Peter

AU - Farrell, B

AU - King, A

AU - Juszczak, E

AU - Darlow, B

AU - Haque, K

AU - Salt, Alison

AU - Stenson, Ben

AU - Tarnow-Mordi, William

AU - Brearley, S

AU - Leslie, A

AU - Stephenson, J

AU - Ashby, D

AU - Cockburn, F

AU - Grant, A

AU - McClelland, B

AU - Modi, Neil

AU - Thornton, H

AU - Altman, D

AU - Cooke, R

AU - Dobson, S

AU - Greene, B

AU - Greisen, G

AU - Neal, T

AU - Pradhan, F

AU - Walden, B

AU - Williams, R

AU - Armstrong, N

AU - Ayers, S

AU - Baker, P

AU - Bowler, U

AU - Catterall, B

AU - Cavendish, V

AU - Chan-Fook, C

AU - Duxbury, M

AU - Evans, D

AU - Gates, S

AU - Hawcutt, D

AU - Logan, M

AU - McElroy, H

AU - Mohan, P

AU - Morgan-Jones, E

AU - Notman, J

AU - Redshaw, M

AU - Shakeshaft, C

AU - Stevens, C

AU - Williams, S

AU - Zhao, R

AU - Hague, W

AU - Henderson-Smart, D

AU - Isaacs, David

AU - Simes, John

AU - Sebastian, L

AU - Barsenbach, R

AU - Blanco, J

AU - Brown, C

AU - Cust, A

AU - Duggal-Berri, P

AU - Gebski, V

AU - Hay, M

AU - O'Regan, L

AU - Pillai, A

AU - Mann, K

AU - Martin, A

AU - Sitha, S

AU - van Host Pellekaan, C

AU - Abalos, E

AU - Carroli, B

AU - Carroli, G

AU - Rizzi, R

AU - Sguassero, Y

AU - Garcia, R

AU - Raineri, A

AU - Falco, O

AU - Redondo, F

AU - Farri, M

AU - Funes, S

AU - Burgaretta, C

AU - Ramirez, L

AU - Fernandez, F

AU - Levinson, L

AU - Agudo, E

AU - Bisbal, M

AU - Guerrero, M

AU - Szyld, E

AU - Brazda, G

AU - Deguer, C

AU - Ceriani Cernadas, J

AU - Cravedi, V

AU - Leyton, A

AU - Prado, A

AU - Rodrigue, D

AU - Herrera, N

AU - Murad, M

AU - Aguirre, J

AU - Arosio, S

AU - Picon, C

AU - Posse, N

AU - Rolon, S

AU - Vacou, P

AU - Buking, C

AU - Soto Conti, C

AU - Deckert, M

AU - Kronemberger, M

AU - Navarro, I

AU - Turturici, M

AU - Collino, E

AU - Peyrano, A

AU - Bouceau, N

AU - Bruni, M

AU - Parga, L

AU - Varela, D

AU - Sachetti, P

AU - Alem, M

AU - Camusso, H

AU - Oviedo, A

AU - Ponce de Leon, P

AU - Diaz, Rafael

AU - Morante, J

AU - Puig, G

AU - del Barco, M

AU - Filtrin, M

AU - Oliveira, F

AU - Halac, E

AU - Alberto, G

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AU - O'Brien, R

PY - 2011/9/29

Y1 - 2011/9/29

N2 - BACKGROUND: Neonatal sepsis is a major cause of death and complications despite antibiotic treatment. Effective adjunctive treatments are needed. Newborn infants are relatively deficient in endogenous immunoglobulin. Meta-analyses of trials of intravenous immune globulin for suspected or proven neonatal sepsis suggest a reduced rate of death from any cause, but the trials have been small and have varied in quality. METHODS: At 113 hospitals in nine countries, we enrolled 3493 infants receiving antibiotics for suspected or proven serious infection and randomly assigned them to receive two infusions of either polyvalent IgG immune globulin (at a dose of 500 mg per kilogram of body weight) or matching placebo 48 hours apart. The primary outcome was death or major disability at the age of 2 years. RESULTS: There was no significant between-group difference in the rates of the primary outcome, which occurred in 686 of 1759 infants (39.0%) who received intravenous immune globulin and in 677 of 1734 infants (39.0%) who received placebo (relative risk, 1.00; 95% confidence interval, 0.92 to 1.08). Similarly, there were no significant differences in the rates of secondary outcomes, including the incidence of subsequent sepsis episodes. In follow-up of 2-year-old infants, there were no significant differences in the rates of major or nonmajor disability or of adverse events. CONCLUSIONS: Therapy with intravenous immune globulin had no effect on the outcomes of suspected or proven neonatal sepsis. (Funded by the United Kingdom Medical Research Council and others; INIS Current Controlled Trials number, ISRCTN94984750.).

AB - BACKGROUND: Neonatal sepsis is a major cause of death and complications despite antibiotic treatment. Effective adjunctive treatments are needed. Newborn infants are relatively deficient in endogenous immunoglobulin. Meta-analyses of trials of intravenous immune globulin for suspected or proven neonatal sepsis suggest a reduced rate of death from any cause, but the trials have been small and have varied in quality. METHODS: At 113 hospitals in nine countries, we enrolled 3493 infants receiving antibiotics for suspected or proven serious infection and randomly assigned them to receive two infusions of either polyvalent IgG immune globulin (at a dose of 500 mg per kilogram of body weight) or matching placebo 48 hours apart. The primary outcome was death or major disability at the age of 2 years. RESULTS: There was no significant between-group difference in the rates of the primary outcome, which occurred in 686 of 1759 infants (39.0%) who received intravenous immune globulin and in 677 of 1734 infants (39.0%) who received placebo (relative risk, 1.00; 95% confidence interval, 0.92 to 1.08). Similarly, there were no significant differences in the rates of secondary outcomes, including the incidence of subsequent sepsis episodes. In follow-up of 2-year-old infants, there were no significant differences in the rates of major or nonmajor disability or of adverse events. CONCLUSIONS: Therapy with intravenous immune globulin had no effect on the outcomes of suspected or proven neonatal sepsis. (Funded by the United Kingdom Medical Research Council and others; INIS Current Controlled Trials number, ISRCTN94984750.).

UR - http://www.scopus.com/inward/record.url?scp=80053367664&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa1100441

DO - 10.1056/NEJMoa1100441

M3 - Article

SN - 0028-4793

VL - 365

SP - 1201

EP - 1211

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 13

ER -

Treatment of neonatal sepsis with intravenous immune globulin

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