| Treatment of neonatal sepsis with intravenous immune globulin. | |
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MedLine Citation:
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PMID: 21962214 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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; 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:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The New England journal of medicine Volume: 365 ISSN: 1533-4406 ISO Abbreviation: N. Engl. J. Med. Publication Date: 2011 Sep |
Date Detail:
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Created Date: 2011-10-03 Completed Date: 2011-10-19 Revised Date: 2012-01-06 |
Medline Journal Info:
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Nlm Unique ID: 0255562 Medline TA: N Engl J Med Country: United States |
Other Details:
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Languages: eng Pagination: 1201-11 Citation Subset: AIM; IM |
Affiliation:
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National Perinatal Epidemiology Unit, University of Oxford, Old Road Campus, Headington, Oxford OX3 7LF, United Kingdom. |
| Data Bank Information | |
Bank Name/Acc. No.:
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ISRCTN/ISRCTN94984750 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Anti-Bacterial Agents
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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:
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//Medical Research Council |
| Chemical | |
Reg. No./Substance:
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0/Anti-Bacterial Agents; 0/Immunoglobulins, Intravenous; 0/Immunologic Factors |
| Investigator | |
Investigator/Affiliation:
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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:
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N Engl J Med. 2012 Jan 5;366(1):91; author reply 91
[PMID:
22216854
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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