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

Luke C Mullany, Shams El Arifeen, Peter John Winch, Rasheduzzaman Shah, Ishtiaq Mannan, Syed M. Rahman, Mohammad R. Rahman, Gary L. Darmstadt, Saifuddin Ahmed, Mathuram Santosham, Robert E Black, Abdullah Baqui

Research output: Contribution to journalArticle

Abstract

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).

Original languageEnglish (US)
Article number1471
Pages (from-to)67
Number of pages1
JournalBMC Pediatrics
Volume9
DOIs
StatePublished - Oct 21 2009

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Chlorhexidine
Bangladesh
Umbilical Cord
Newborn Infant
Mortality
Nepal
Infant Mortality
Parturition
Hand Disinfection
House Calls
Pregnancy Outcome
Health Promotion
Mothers
Guidelines
Pregnancy
Infection

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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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. / Mullany, Luke C; El Arifeen, Shams; Winch, Peter John; Shah, Rasheduzzaman; Mannan, Ishtiaq; Rahman, Syed M.; Rahman, Mohammad R.; Darmstadt, Gary L.; Ahmed, Saifuddin; Santosham, Mathuram; Black, Robert E; Baqui, Abdullah.

In: BMC Pediatrics, Vol. 9, 1471, 21.10.2009, p. 67.

Research output: Contribution to journalArticle

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abstract = "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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AU - Shah, Rasheduzzaman

AU - Mannan, Ishtiaq

AU - Rahman, Syed M.

AU - Rahman, Mohammad R.

AU - Darmstadt, Gary L.

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