Document Detail


Treatment of neonatal sepsis with intravenous immune globulin.
MedLine Citation:
PMID:  21962214     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
; Peter Brocklehurst; Barbara Farrell; Andrew King; Edmund Juszczak; Brian Darlow; Khalid Haque; Alison Salt; Ben Stenson; William Tarnow-Mordi
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  365     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2011 Sep 
Date Detail:
Created Date:  2011-10-03     Completed Date:  2011-10-19     Revised Date:  2014-02-20    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1201-11     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ISRCTN/ISRCTN94984750
Export Citation:
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MeSH Terms
Descriptor/Qualifier:
Anti-Bacterial Agents / therapeutic use
Double-Blind Method
Drug Therapy, Combination
Female
Gram-Positive Bacterial Infections / drug therapy
Humans
Immunoglobulins, Intravenous / therapeutic use*
Immunologic Factors / therapeutic use*
Infant, Newborn
Male
Recurrence / prevention & control
Risk
Sepsis / drug therapy*
Staphylococcal Infections / drug therapy
Grant Support
ID/Acronym/Agency:
G9900825//Medical Research Council; //Medical Research Council
Chemical
Reg. No./Substance:
0/Anti-Bacterial Agents; 0/Immunoglobulins, Intravenous; 0/Immunologic Factors
Investigator
Investigator/Affiliation:
S Brearley / ; P Brocklehurst / ; K Haque / ; A Leslie / ; B Stenson / ; A Salt / ; J Stephenson / ; W Tarnow-Mordi / ; D Ashby / ; F Cockburn / ; A Grant / ; B Juszczak / ; B McClelland / ; N Modi / ; H Thornton / ; D Altman / ; P Brocklehurst / ; R Cooke / ; S Dobson / ; B Greene / ; G Greisen / ; T Neal / ; F Pradhan / ; W Tarnow-Mordi / ; B Walden / ; R Williams / ; P Brocklehurst / ; B Farrell / ; E Juszczak / ; A King / ; 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 Tarnow-Mordi / ; B Darlow / ; W Hague / ; D Henderson-Smart / ; D Isaccs / ; J Simes / ; L Sebastian / ; R Barsenbach / ; J Blanco / ; C Brown / ; A Cust / ; P Guggal-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 T García / ; A Raineri / ; O Falcó / ; F Redondo / ; M Farri / ; S M Funes / ; C Burgaretta / ; L Ramirez / ; F Fernandez / ; L Levinson / ; E Agudo / ; M Bisbal / ; M Guerrero / ; E Szyld / ; G Brazda / ; C A Deguer / ; J M Ceriani Cernadas / ; V Cravedi / ; A Leyton / ; A Prado / ; N R Herrera / ; M Murad / ; J D Aguirre / ; S Arosio / ; C Picón / ; N Posse / ; S V Rolón / ; P Vacou / ; C Buking / ; C P Soto Conti / ; M Deckert / ; M Kronemberger / ; I Navarro / ; E Collino / ; A J Peyrano / ; N Bouceau / ; M T Bruni / ; L Parga / ; D M Varela / ; L Levinson / ; P Sachetti / ; M I Alem / ; H C Camusso / ; A Oviedo / ; P A Ponce de León / ; R Díaz / ; J Morante / ; G Puig / ; M del Barco / ; M R Filtrín / ; F Oliveira / ; E Halac / ; G Alberto / ; S Meskell / ; G Reynolds / ; P Craven / ; L Hobson / ; K Meredith / ; C Chambers / ; J Phelps / ; S 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 / ; J Mills / ; L Perkins / ; C Plover / ; K Butterley / ; P 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 / ; W Tarnow-Mordi / ; B Twible / ; V Bhatia / ; L Goodchild / ; K Western / ; V Cossey / ; M Dahl / ; J Reinholdt / ; B Hoest / ; L Vad Pedersen / ; H Dellagrammaticas / ; N Iacovidou / ; L Bradfield / ; B P Murphy / ; C A Ryan / ; M Gojic / ; B Vasiljevic / ; B Darlow / ; N McNeill / ; D Pugh-Williams / ; R Broadbent / ; F McCaffrey / ; O Johnson / ; T Bushell / ; J L'Anson / ; M Wong / ; M 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 A Saeed / ; C Maybor / ; S J Rose / ; S L Chatfield / ; S Szpara / ; L Elliot / ; T Soe / ; J Nycyk / ; M Perry / ; D Freeman / ; D Rogahn / ; H Kirby / ; J Madar / ; P Adiotomre / ; J Watkinson / ; N H D Al Hilaly / ; V Wijetunge / ; J Simpson / ; R Wakefield / ; S Ainsworth / ; K McCormack / ; M Peters / ; H Tighe / ; M Cruwys / ; M C Hoong / ; E Crosbie / ; A Knapton / ; M K Lal / ; B Whalley / ; H Pentelow / ; P Rao / ; H Doyle / ; J Chang / ; S Lam / ; B R 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 E Thambapillai / ; A Powls / ; S Provan / ; P Fox / ; S Rubin / ; W C 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 / ; B Stenson / ; 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 R Groves / ; A Jain / ; C Waite / ; T Otunla / ; M Woodford / ; R Arya / ; M Qasim / ; S Sivashankar / ; S Armstrong / ; R C Coombs / ; D Garvie / ; S Holmes / ; A Gupta / ; J M Bradshaw / ; P Satodia / ; A Glennard / ; R D 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 /
Comments/Corrections
Comment In:
N Engl J Med. 2012 Jan 5;366(1):91; author reply 91   [PMID:  22216854 ]

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