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Randomized Trial of BCG Vaccination at Birth to Low-Birth-Weight Children: Beneficial Nonspecific Effects in the Neonatal Period?

The Journal of infectious diseases, 2011-07, Vol.204 (2), p.245-252 [Peer Reviewed Journal]

Copyright © 2011 Oxford University Press on behalf of the Infectious Diseases Society of America ;The Author 2011. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com 2011 ;2015 INIST-CNRS ;ISSN: 0022-1899 ;ISSN: 1537-6613 ;EISSN: 1537-6613 ;DOI: 10.1093/infdis/jir240 ;PMID: 21673035 ;CODEN: JIDIAQ

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Title:
Randomized Trial of BCG Vaccination at Birth to Low-Birth-Weight Children: Beneficial Nonspecific Effects in the Neonatal Period?
Author: Aaby, Peter ; Roth, Adam ; Ravn, Henrik ; Napirna, Bitiguida Mutna ; Rodrigues, Amabelia ; Lisse, Ida Maria ; Stensballe, Lone ; Diness, Birgitte Rode ; Lausch, Karen Rokkedal ; Lund, Najaaraq ; Biering-Sørensen, Sofie ; Whittle, Hilton ; Benn, Christine Stabell
Subjects: Bacillus calmette guerin vaccine ; BACTERIA ; BCG Vaccine - administration & dosage ; BCG Vaccine - adverse effects ; BCG Vaccine - immunology ; Biological and medical sciences ; Child nutrition ; Children ; Clinical Medicine ; Control groups ; Experimentation ; Female ; Fundamental and applied biological sciences. Psychology ; Guinea-Bissau ; Humans ; Infant Mortality ; Infant, Low Birth Weight ; Infant, Newborn ; Infectious diseases ; Infectious Medicine ; Infektionsmedicin ; Klinisk medicin ; Male ; Medical and Health Sciences ; Medical sciences ; Medicin och hälsovetenskap ; Microbiology ; Mortality ; Random allocation ; Tuberculosis - prevention & control ; Vaccination ; Vaccination - methods ; Vitamin A
Is Part Of: The Journal of infectious diseases, 2011-07, Vol.204 (2), p.245-252
Description: Background. Observational studies have suggested that BCG may have nonspecific beneficial effects on survival. Low-birth-weight (LBW) children are not given BCG at birth in Guinea-Bissau; we conducted a randomized trial of BCG at birth (early BCG) vs delayed BCG. Methods, In the period 2004—2008 we recruited 2320 LBW children in Bissau. The children were visited at home at 2, 6, and 12 months of age. With a pretrial infant mortality of 250 per 1000, we hypothesized a 25% reduction in infant mortality for LBW children. Results. Infant mortality was only 101 per 1000 during the trial. In the primary analysis, infant mortality was reduced insignificantly by 17% (mortality rate ratio [MRR] = .83 [.63—1.08]). In secondary analyses, early BCG vaccine was safe with an MRR of .49 (.21—1.15) after 3 days and .55 (.34—.89) after 4 weeks. The reduction in neonatal mortality was mainly due to fewer cases of neonatal sepsis, respiratory infection, and fever. The impact of early BCG on infant mortality was marked for children weighing < 1.5 kg (MRR = .43 [.21—.85]) who had lower coverage for diphtheria-tetanus-pertussis vaccinations. Conclusions. Though early BCG did not reduce infant mortality significantly, it may have a beneficial effect in the neonatal period. This could be important for public health because BCG is often delayed in low-income countries.
Publisher: Oxford: Oxford University Press
Language: English
Identifier: ISSN: 0022-1899
ISSN: 1537-6613
EISSN: 1537-6613
DOI: 10.1093/infdis/jir240
PMID: 21673035
CODEN: JIDIAQ
Source: Geneva Foundation Free Medical Journals at publisher websites
MEDLINE
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Randomized Trial of BCG Vaccination at Birth to Low-Birth-Weight Children: Beneficial Nonspecific Effects in the Neonatal Period?

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