Document Detail

Topical application of chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan: a community-based, cluster-randomised trial.
MedLine Citation:
PMID:  22322126     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Umbilical cord infection (omphalitis) is a risk factor for neonatal sepsis and mortality in low-resource settings where home deliveries are common. We aimed to assess the effect of umbilical-cord cleansing with 4% chlorhexidine (CHX) solution, with or without handwashing with antiseptic soap, on the incidence of omphalitis and neonatal mortality.
METHODS: We did a two-by-two factorial, cluster-randomised trial in Dadu, a rural area of Sindh province, Pakistan. Clusters were defined as the population covered by a functional traditional birth attendant (TBA), and were randomly allocated to one of four groups (groups A to D) with a computer-generated random number sequence. Implementation and data collection teams were masked to allocation. Liveborn infants delivered by participating TBAs who received birth kits were eligible for enrolment in the study. One intervention comprised birth kits containing 4% CHX solution for application to the cord at birth by TBAs and once daily by family members for up to 14 days along with soap and educational messages promoting handwashing. One intervention was CHX solution only and another was handwashing only. Standard dry cord care was promoted in the control group. The primary outcomes were incidence of neonatal omphalitis and neonatal mortality. The trial is registered with, number NCT00682006.
FINDINGS: 187 clusters were randomly allocated to one of the four study groups. Of 9741 newborn babies delivered by participating TBAs, factorial analysis indicated a reduction in risk of omphalitis with CHX application (risk ratio [RR]=0·58, 95% CI 0·41-0·82; p=0·002) but no evidence of an effect of handwashing (RR=0·83, 0·61-1·13; p=0·24). We recorded strong evidence of a reduction in neonatal mortality in neonates who received CHX cleansing (RR=0·62, 95 % CI 0·45-0·85; p=0·003) but no evidence of an effect of handwashing promotion on neonatal mortality (RR=1·08, 0·79-1·48; p=0·62). We recorded no serious adverse events.
INTERPRETATION: Application of 4% CHX to the umbilical cord was effective in reducing the risk of omphalitis and neonatal mortality in rural Pakistan. Provision of CHX in birth kits might be a useful strategy for the prevention of neonatal mortality in high-mortality settings.
FUNDING: The United States Agency for International Development.
Sajid Soofi; Simon Cousens; Aamer Imdad; Naveed Bhutto; Nabeela Ali; Zulfiqar A Bhutta
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-02-08
Journal Detail:
Title:  Lancet     Volume:  379     ISSN:  1474-547X     ISO Abbreviation:  Lancet     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-03-19     Completed Date:  2012-03-27     Revised Date:  2013-01-10    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  England    
Other Details:
Languages:  eng     Pagination:  1029-36     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2012 Elsevier Ltd. All rights reserved.
Division of Women and Child Health, Aga Khan University, Karachi, Pakistan.
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MeSH Terms
Anti-Infective Agents, Local / administration & dosage*
Bacterial Infections / epidemiology,  prevention & control*
Chlorhexidine / administration & dosage*
Home Childbirth
Infant Mortality
Infant, Newborn
Pakistan / epidemiology
Rural Population
Sepsis / epidemiology,  prevention & control
Umbilical Cord / microbiology*
Reg. No./Substance:
0/Anti-Infective Agents, Local; 55-56-1/Chlorhexidine
Comment In:
Lancet. 2012 Mar 17;379(9820):984-6   [PMID:  22322125 ]
Arch Dis Child Educ Pract Ed. 2012 Dec;97(6):236-7   [PMID:  22904564 ]

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