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    
Abstract/OtherAbstract:
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 ClinicalTrials.gov, 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.
Authors:
Sajid Soofi; Simon Cousens; Aamer Imdad; Naveed Bhutto; Nabeela Ali; Zulfiqar A Bhutta
Related Documents :
22274546 - Does necrotizing enterocolitis affect growth and neurodevelopmental outcome in very low...
22768386 - Exhaled nitric oxide in acute phase of bronchiolitis and its relation with episodes of ...
22970666 - Turn and face the strange - ch..ch..ch..changes to neonatal resuscitation guidelines in...
21324046 - Defining awakening from anesthesia in neonates: a consensus study.
3570426 - Lactate dehydrogenase isoenzyme patterns in human foetal tissues during development.
11566686 - In vivo visualization of pyloric mucosal hypertrophy in infants with hypertrophic pylor...
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.
Affiliation:
Division of Women and Child Health, Aga Khan University, Karachi, Pakistan.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00682006
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Anti-Infective Agents, Local / administration & dosage*
Bacterial Infections / epidemiology,  prevention & control*
Chlorhexidine / administration & dosage*
Female
Home Childbirth
Humans
Infant Mortality
Infant, Newborn
Midwifery
Pakistan / epidemiology
Pregnancy
Rural Population
Sepsis / epidemiology,  prevention & control
Umbilical Cord / microbiology*
Chemical
Reg. No./Substance:
0/Anti-Infective Agents, Local; 55-56-1/Chlorhexidine
Comments/Corrections
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 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a communi...
Next Document:  Managing wastewater effluent to enhance aquatic receiving ecosystem productivity: A coastal lagoon i...