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rft.atitle Randomized Trial of BCG Vaccination at Birth to Low-Birth-Weight Children: Beneficial Nonspecific Effects in the Neonatal Period?
rft.epage 252
rft.genre article
rft.issn 0022-1899
rft.issue 2
rft.jtitle The Journal of Infectious Diseases
rft.tpages 7
rft.pages 245-252
rft.pub Oxford University Press
rft.date 2011-07-15
x.date 2011-07-15T00:00:00Z
rft.spage 245
rft.volume 204
abstract <p>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 &lt; 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.</p>
authors Array ( [rft.aulast] => Aaby [rft.aufirst] => Peter )
Array ( [rft.aulast] => Roth [rft.aufirst] => Adam )
Array ( [rft.aulast] => Ravn [rft.aufirst] => Henrik )
Array ( [rft.aulast] => Napirna [rft.aufirst] => Bitiguida Mutna )
Array ( [rft.aulast] => Rodrigues [rft.aufirst] => Amabelia )
Array ( [rft.aulast] => Lisse [rft.aufirst] => Ida Maria )
Array ( [rft.aulast] => Stensballe [rft.aufirst] => Lone )
Array ( [rft.aulast] => Diness [rft.aufirst] => Birgitte Rode )
Array ( [rft.aulast] => Lausch [rft.aufirst] => Karen Rokkedal )
Array ( [rft.aulast] => Lund [rft.aufirst] => Najaaraq )
Array ( [rft.aulast] => Biering-Sørensen [rft.aufirst] => Sofie )
Array ( [rft.aulast] => Whittle [rft.aufirst] => Hilton )
Array ( [rft.aulast] => Benn [rft.aufirst] => Christine Stabell )
doi 10.1093/infdis/jir240
languages eng
url http://dx.doi.org/10.1093/infdis/jir240
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x.subjects MAJOR ARTICLES AND BRIEF REPORTS
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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
author_facet 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, 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
author_sort aaby, peter
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container_issue 2
container_start_page 245
container_title The Journal of Infectious Diseases
container_volume 204
description <p>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 &lt; 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.</p>
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spelling 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 0022-1899 Oxford University Press MAJOR ARTICLES AND BRIEF REPORTS http://dx.doi.org/10.1093/infdis/jir240 <p>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 &lt; 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.</p> Randomized Trial of BCG Vaccination at Birth to Low-Birth-Weight Children: Beneficial Nonspecific Effects in the Neonatal Period? The Journal of Infectious Diseases
spellingShingle 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, The Journal of Infectious Diseases, Randomized Trial of BCG Vaccination at Birth to Low-Birth-Weight Children: Beneficial Nonspecific Effects in the Neonatal Period?, MAJOR ARTICLES AND BRIEF REPORTS
title Randomized Trial of BCG Vaccination at Birth to Low-Birth-Weight Children: Beneficial Nonspecific Effects in the Neonatal Period?
title_full Randomized Trial of BCG Vaccination at Birth to Low-Birth-Weight Children: Beneficial Nonspecific Effects in the Neonatal Period?
title_fullStr Randomized Trial of BCG Vaccination at Birth to Low-Birth-Weight Children: Beneficial Nonspecific Effects in the Neonatal Period?
title_full_unstemmed Randomized Trial of BCG Vaccination at Birth to Low-Birth-Weight Children: Beneficial Nonspecific Effects in the Neonatal Period?
title_short Randomized Trial of BCG Vaccination at Birth to Low-Birth-Weight Children: Beneficial Nonspecific Effects in the Neonatal Period?
title_sort randomized trial of bcg vaccination at birth to low-birth-weight children: beneficial nonspecific effects in the neonatal period?
title_unstemmed Randomized Trial of BCG Vaccination at Birth to Low-Birth-Weight Children: Beneficial Nonspecific Effects in the Neonatal Period?
topic MAJOR ARTICLES AND BRIEF REPORTS
url http://dx.doi.org/10.1093/infdis/jir240