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Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of a community-based cluster randomized trial

BACKGROUND: The World Health Organization recommends dry cord care for newborns but this recommendation may not be optimal in low resource settings where most births take place in an unclean environment and infections account for up to half of neonatal deaths. A previous trial in Nepal indicated tha...

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Autores principales: Mullany, Luke C, El Arifeen, Shams, Winch, Peter J, Shah, Rasheduzzaman, Mannan, Ishtiaq, Rahman, Syed M, Rahman, Mohammad R, Darmstadt, Gary L, Ahmed, Saifuddin, Santosham, Mathuram, Black, Robert E, Baqui, Abdullah H
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2009
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2770449/
https://www.ncbi.nlm.nih.gov/pubmed/19845951
http://dx.doi.org/10.1186/1471-2431-9-67
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author Mullany, Luke C
El Arifeen, Shams
Winch, Peter J
Shah, Rasheduzzaman
Mannan, Ishtiaq
Rahman, Syed M
Rahman, Mohammad R
Darmstadt, Gary L
Ahmed, Saifuddin
Santosham, Mathuram
Black, Robert E
Baqui, Abdullah H
author_facet Mullany, Luke C
El Arifeen, Shams
Winch, Peter J
Shah, Rasheduzzaman
Mannan, Ishtiaq
Rahman, Syed M
Rahman, Mohammad R
Darmstadt, Gary L
Ahmed, Saifuddin
Santosham, Mathuram
Black, Robert E
Baqui, Abdullah H
author_sort Mullany, Luke C
collection PubMed
description BACKGROUND: The World Health Organization recommends dry cord care for newborns but this recommendation may not be optimal in low resource settings where most births take place in an unclean environment and infections account for up to half of neonatal deaths. A previous trial in Nepal indicated that umbilical cord cleansing with 4.0% chlorhexidine could substantially reduce mortality and omphalitis risk, but policy changes await additional community-based data. METHODS: The Projahnmo Chlorhexidine study was a three-year, cluster-randomized, community-based trial to assess the impact of three cord care regimens on neonatal mortality and omphalitis. Women were recruited mid-pregnancy, received a basic package of maternal and neonatal health promotion messages, and were followed to pregnancy outcome. Newborns were visited at home by local village-based workers whose areas were randomized to either 1) single- or 2) 7-day cord cleansing with 4.0% chlorhexidine, or 3) promotion of dry cord care as recommended by WHO. All mothers received basic messages regarding hand-washing, clean cord cutting, and avoidance of harmful home-base applications to the cord. Death within 28 days and omphalitis were the primary outcomes; these were monitored directly through home visits by community health workers on days 1, 3, 6, 9, 15, and 28 after birth. DISCUSSION: Due to report in early 2010, the Projahnmo Chlorhexidine Study examines the impact of multiple or single chlorhexidine cleansing of the cord on neonatal mortality and omphalitis among newborns of rural Sylhet District, Bangladesh. The results of this trial will be interpreted in conjunction with a similarly designed trial previously conducted in Nepal, and will have implications for policy guidelines for optimal cord care of newborns in low resource settings in Asia. TRIAL REGISTRATION: ClinicalTrials.gov (NCT00434408)
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spelling pubmed-27704492009-10-30 Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of a community-based cluster randomized trial Mullany, Luke C El Arifeen, Shams Winch, Peter J Shah, Rasheduzzaman Mannan, Ishtiaq Rahman, Syed M Rahman, Mohammad R Darmstadt, Gary L Ahmed, Saifuddin Santosham, Mathuram Black, Robert E Baqui, Abdullah H BMC Pediatr Study Protocol BACKGROUND: The World Health Organization recommends dry cord care for newborns but this recommendation may not be optimal in low resource settings where most births take place in an unclean environment and infections account for up to half of neonatal deaths. A previous trial in Nepal indicated that umbilical cord cleansing with 4.0% chlorhexidine could substantially reduce mortality and omphalitis risk, but policy changes await additional community-based data. METHODS: The Projahnmo Chlorhexidine study was a three-year, cluster-randomized, community-based trial to assess the impact of three cord care regimens on neonatal mortality and omphalitis. Women were recruited mid-pregnancy, received a basic package of maternal and neonatal health promotion messages, and were followed to pregnancy outcome. Newborns were visited at home by local village-based workers whose areas were randomized to either 1) single- or 2) 7-day cord cleansing with 4.0% chlorhexidine, or 3) promotion of dry cord care as recommended by WHO. All mothers received basic messages regarding hand-washing, clean cord cutting, and avoidance of harmful home-base applications to the cord. Death within 28 days and omphalitis were the primary outcomes; these were monitored directly through home visits by community health workers on days 1, 3, 6, 9, 15, and 28 after birth. DISCUSSION: Due to report in early 2010, the Projahnmo Chlorhexidine Study examines the impact of multiple or single chlorhexidine cleansing of the cord on neonatal mortality and omphalitis among newborns of rural Sylhet District, Bangladesh. The results of this trial will be interpreted in conjunction with a similarly designed trial previously conducted in Nepal, and will have implications for policy guidelines for optimal cord care of newborns in low resource settings in Asia. TRIAL REGISTRATION: ClinicalTrials.gov (NCT00434408) BioMed Central 2009-10-21 /pmc/articles/PMC2770449/ /pubmed/19845951 http://dx.doi.org/10.1186/1471-2431-9-67 Text en Copyright © 2009 Mullany et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( (http://creativecommons.org/licenses/by/2.0) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Mullany, Luke C
El Arifeen, Shams
Winch, Peter J
Shah, Rasheduzzaman
Mannan, Ishtiaq
Rahman, Syed M
Rahman, Mohammad R
Darmstadt, Gary L
Ahmed, Saifuddin
Santosham, Mathuram
Black, Robert E
Baqui, Abdullah H
Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of a community-based cluster randomized trial
title Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of a community-based cluster randomized trial
title_full Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of a community-based cluster randomized trial
title_fullStr Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of a community-based cluster randomized trial
title_full_unstemmed Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of a community-based cluster randomized trial
title_short Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of a community-based cluster randomized trial
title_sort impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of sylhet, bangladesh: design of a community-based cluster randomized trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2770449/
https://www.ncbi.nlm.nih.gov/pubmed/19845951
http://dx.doi.org/10.1186/1471-2431-9-67
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